Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT04423393
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2020-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@vir.bio', 'phone': '(415) 906-4324', 'title': 'Study Inquiry', 'organization': 'Vir Biotechnology, Inc.'}, 'certainAgreement': {'otherDetails': 'Investigators may discuss or publish results after:\n\n* the study results in their entirety have been publicly disclosed by or with the consent of the Sponsor OR study has been completed at all investigative sites for at least 18 months.\n* provision of publication up to 60 days before planned submission to allow Sponsor to remove confidential information or identify Sponsor intellectual property\n\nPublication may be delayed as applicable, up to 120 days for Sponsor to file patent application(s)', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part A Healthy Participants Placebo', 'description': 'Healthy participants received placebo subcutaneously or intravenously', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 6, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Part B: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received placebo subcutaneous', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG014', 'title': 'Part C: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received placebo subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG016', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG017', 'title': 'Part D: HBV Participants Placebo', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 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0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG012', 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'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaphylactic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '4', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'OG004', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}, {'id': 'OG005', 'title': 'Part A Healthy Participants Placebo', 'description': 'Healthy participants received placebo subcutaneously or intravenously'}, {'id': 'OG006', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'OG007', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG008', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG009', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG010', 'title': 'Part B: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received placebo subcutaneous'}, {'id': 'OG011', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG012', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG013', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG014', 'title': 'Part C: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received placebo subcutaneous'}, {'id': 'OG015', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG016', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG017', 'title': 'Part D: HBV Participants Placebo', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '4', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'OG004', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}, {'id': 'OG005', 'title': 'Part A Healthy Participants Placebo', 'description': 'Healthy participants received placebo subcutaneously or intravenously'}, {'id': 'OG006', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'OG007', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG008', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG009', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG010', 'title': 'Part B: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received placebo subcutaneous'}, {'id': 'OG011', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG012', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG013', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG014', 'title': 'Part C: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received placebo subcutaneous'}, {'id': 'OG015', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG016', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG017', 'title': 'Part D: HBV Participants Placebo', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous'}], 'classes': [{'title': 'ALT Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'ALT Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'ALT Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'ALT Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'Alkaline phosphatase Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'Alkaline phosphatase Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'Alkaline phosphatase Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'Alkaline phosphatase Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'AST Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'AST Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'AST Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'AST Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'Bilirubin Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'Bilirubin Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'Bilirubin Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'Bilirubin Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 280 days post-dose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG004', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG005', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG006', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG007', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG008', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '352', 'spread': '27.0', 'groupId': 'OG000'}, {'value': '456', 'spread': '152.8', 'groupId': 'OG001'}, {'value': '5460', 'spread': '36.5', 'groupId': 'OG002'}, {'value': '19700', 'spread': '56.9', 'groupId': 'OG003'}, {'value': '835', 'spread': 'NA', 'comment': 'In the 18 mg cohort in Part C, 2 participants among the 3 who had quantifiable PK concentrations only had 2 non-BQL values, so PK parameters were excluded from summary statistics. CV% was only reported when n ≥ 3, so indicated as NA in this case.', 'groupId': 'OG004'}, {'value': '4750', 'spread': '46.9', 'groupId': 'OG005'}, {'value': '26100', 'spread': '21.8', 'groupId': 'OG006'}, {'value': '6000', 'spread': '16.8', 'groupId': 'OG007'}, {'value': '10800', 'spread': '61.4', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 Maximum Concentration in Serum', 'unitOfMeasure': 'Parts B-D: ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set'}, {'type': 'SECONDARY', 'title': 'Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'OG004', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}, {'id': 'OG005', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'OG006', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG007', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG008', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG009', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG010', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG011', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG012', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG013', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '7.01'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '7.00'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '3.00', 'upperLimit': '7.00'}, {'value': '.0833', 'groupId': 'OG003', 'lowerLimit': '0.0417', 'upperLimit': '0.292'}, {'value': '.0833', 'groupId': 'OG004', 'lowerLimit': '0.0417', 'upperLimit': '0.0847'}, {'value': '6.90', 'groupId': 'OG005', 'lowerLimit': '1.01', 'upperLimit': '7.00'}, {'value': '2.92', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '6.88'}, {'value': '5.44', 'groupId': 'OG007', 'lowerLimit': '2.83', 'upperLimit': '7.03'}, {'value': '2.96', 'groupId': 'OG008', 'lowerLimit': '2.11', 'upperLimit': '6.97'}, {'value': '3.98', 'groupId': 'OG009', 'lowerLimit': '3.98', 'upperLimit': '3.98'}, {'value': '3.00', 'groupId': 'OG010', 'lowerLimit': '2.95', 'upperLimit': '3.94'}, {'value': '2.99', 'groupId': 'OG011', 'lowerLimit': '2.86', 'upperLimit': '6.97'}, {'value': '4.08', 'groupId': 'OG012', 'lowerLimit': '0.0417', 'upperLimit': '8.11'}, {'value': '2.99', 'groupId': 'OG013', 'lowerLimit': '2.91', 'upperLimit': '3.15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 time of Cmax in Serum', 'unitOfMeasure': 'day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with BQL at all time points were excluded from the PK analysis, hence for different n in the cohorts. CV was only calculated if the PK parameter was estimated in at least 3 subjects'}, {'type': 'SECONDARY', 'title': 'AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG004', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG005', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG006', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG007', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG008', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '3130', 'spread': '67.5', 'groupId': 'OG000'}, {'value': '4150', 'spread': '270.0', 'groupId': 'OG001'}, {'value': '106000', 'spread': '72.3', 'groupId': 'OG002'}, {'value': '381000', 'spread': '94.2', 'groupId': 'OG003'}, {'value': '9540', 'spread': 'NA', 'comment': 'In the 18 mg cohort in Part C, 2 participants among the 3 who had quantifiable PK concentrations only had 2 non-BQL values, so PK parameters were excluded from summary statistics. CV% was only reported when n ≥ 3, so indicated as NA in this case.', 'groupId': 'OG004'}, {'value': '39000', 'spread': '133.0', 'groupId': 'OG005'}, {'value': '181,000', 'spread': '964.4', 'groupId': 'OG006'}, {'value': '9,270', 'spread': '1,139.9', 'groupId': 'OG007'}, {'value': '54,300', 'spread': '122.7', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 under the curve from time 0 to last measurable Time', 'unitOfMeasure': 'Parts B-D: day*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with BQL at all time points were excluded from the PK analysis, hence for different n in the cohorts.'}, {'type': 'SECONDARY', 'title': 't1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'OG004', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}, {'id': 'OG005', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'OG006', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG007', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG008', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG009', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG010', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG011', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG012', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG013', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '30.3'}, {'value': '24.3', 'groupId': 'OG001', 'lowerLimit': '23.2', 'upperLimit': '26.6'}, {'value': '25.2', 'groupId': 'OG002', 'lowerLimit': '21.6', 'upperLimit': '28.7'}, {'value': '24.0', 'groupId': 'OG003', 'lowerLimit': '20.7', 'upperLimit': '25.7'}, {'value': '20.7', 'groupId': 'OG004', 'lowerLimit': '19.3', 'upperLimit': '22.7'}, {'value': '3.57', 'groupId': 'OG005', 'lowerLimit': '2.33', 'upperLimit': '4.81'}, {'value': '6.34', 'groupId': 'OG006', 'lowerLimit': '6.34', 'upperLimit': '6.34'}, {'value': '7.94', 'groupId': 'OG007', 'lowerLimit': '3.54', 'upperLimit': '17.2'}, {'value': '13.6', 'groupId': 'OG008', 'lowerLimit': '5.96', 'upperLimit': '16.0'}, {'value': '3.82', 'groupId': 'OG009', 'lowerLimit': '3.82', 'upperLimit': '3.82'}, {'value': '4.25', 'groupId': 'OG010', 'lowerLimit': '2.48', 'upperLimit': '6.02'}, {'value': '8.36', 'groupId': 'OG011', 'lowerLimit': '4.16', 'upperLimit': '11.8'}, {'value': '3.17', 'groupId': 'OG012', 'lowerLimit': '3.17', 'upperLimit': '3.17'}, {'value': '1.99', 'groupId': 'OG013', 'lowerLimit': '1.99', 'upperLimit': '1.99'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 apparent Elimination Half-life (t1/2) in serum', 'unitOfMeasure': 'day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Anal;ysis Set'}, {'type': 'SECONDARY', 'title': 'Vz/F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'OG004', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG005', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG006', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG007', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG008', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG009', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG010', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG011', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '12200', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '10900', 'spread': '27.3', 'groupId': 'OG001'}, {'value': '10600', 'spread': '27.7', 'groupId': 'OG002'}, {'value': '9420', 'spread': '12.9', 'groupId': 'OG003'}, {'value': '4540', 'spread': 'NA', 'comment': 'the SAP specified that if span of \\< 2 half-lives or (adjusted) r2 \\< 0.80 or %AUCexp \\>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\\<3, %CV was NA.', 'groupId': 'OG004'}, {'value': '7410', 'spread': '21.5', 'groupId': 'OG005'}, {'value': '9830', 'spread': '54.2', 'groupId': 'OG006'}, {'value': '10300', 'spread': 'NA', 'comment': 'the SAP specified that if span of \\< 2 half-lives or (adjusted) r2 \\< 0.80 or %AUCexp \\>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\\<3, %CV was NA.', 'groupId': 'OG007'}, {'value': '6710', 'spread': '27.4', 'groupId': 'OG008'}, {'value': '7330', 'spread': '22.5', 'groupId': 'OG009'}, {'value': '5000', 'spread': 'NA', 'comment': 'the SAP specified that if span of \\< 2 half-lives or (adjusted) r2 \\< 0.80 or %AUCexp \\>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\\<3, %CV was NA.', 'groupId': 'OG010'}, {'value': '4880', 'spread': 'NA', 'comment': 'the SAP specified that if span of \\< 2 half-lives or (adjusted) r2 \\< 0.80 or %AUCexp \\>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\\<3, %CV was NA.', 'groupId': 'OG011'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 Volume of Distribution (SC only)', 'unitOfMeasure': 'mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set'}, {'type': 'SECONDARY', 'title': 'Vz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'OG001', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}], 'classes': [{'categories': [{'measurements': [{'value': '7620', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '7290', 'spread': '24.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose', 'description': 'VIR-3434 Volume of Distribution (IV only)', 'unitOfMeasure': 'mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CL/F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'OG004', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG005', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG006', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG007', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG008', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG009', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG010', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG011', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '295', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '308', 'spread': '22.7', 'groupId': 'OG001'}, {'value': '292', 'spread': '19.7', 'groupId': 'OG002'}, {'value': '1950', 'spread': '71.2', 'groupId': 'OG003'}, {'value': '496', 'spread': 'NA', 'comment': 'The SAP specified that if span of \\< 2 half-lives or (adjusted) r2 \\< 0.80 or %AUCexp \\>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\\<3, %CV was NA.', 'groupId': 'OG004'}, {'value': '697', 'spread': '71.6', 'groupId': 'OG005'}, {'value': '653', 'spread': '85.6', 'groupId': 'OG006'}, {'value': '1860', 'spread': 'NA', 'comment': 'The SAP specified that if span of \\< 2 half-lives or (adjusted) r2 \\< 0.80 or %AUCexp \\>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\\<3, %CV was NA.', 'groupId': 'OG007'}, {'value': '1200', 'spread': '111.2', 'groupId': 'OG008'}, {'value': '670', 'spread': '32.8', 'groupId': 'OG009'}, {'value': '1090', 'spread': 'NA', 'comment': 'The SAP specified that if span of \\< 2 half-lives or (adjusted) r2 \\< 0.80 or %AUCexp \\>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\\<3, %CV was NA.', 'groupId': 'OG010'}, {'value': '1700', 'spread': 'NA', 'comment': 'The SAP specified that if span of \\< 2 half-lives or (adjusted) r2 \\< 0.80 or %AUCexp \\>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\\<3, %CV was NA.', 'groupId': 'OG011'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 Apparent serum clearance (SC only)', 'unitOfMeasure': 'mL/day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set'}, {'type': 'SECONDARY', 'title': 'CL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'OG001', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}], 'classes': [{'categories': [{'measurements': [{'value': '244', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '1950', 'spread': '71.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose', 'description': 'VIR-3434 Apparent serum clearance (IV only)', 'unitOfMeasure': 'mL/day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ADA to VIR-3434', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'OG004', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}, {'id': 'OG005', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'OG006', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG007', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG008', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG009', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG010', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG011', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG012', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG013', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose', 'description': 'Evaluate the immunogenicity of VIR-3434', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity Analysis Set'}, {'type': 'SECONDARY', 'title': 'Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG004', 'title': 'Part B: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received placebo subcutaneous'}, {'id': 'OG005', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG006', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG007', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG008', 'title': 'Part C: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received placebo subcutaneous'}, {'id': 'OG009', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG010', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG011', 'title': 'Part D: HBV Participants Placebo', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous'}], 'classes': [{'title': 'Nadir', 'categories': [{'measurements': [{'value': '-1.30', 'spread': '0.152', 'groupId': 'OG000'}, {'value': '-1.27', 'spread': '0.666', 'groupId': 'OG001'}, {'value': '-1.96', 'spread': '0.436', 'groupId': 'OG002'}, {'value': '-2.24', 'spread': '0.353', 'groupId': 'OG003'}, {'value': '-0.04', 'spread': '0.039', 'groupId': 'OG004'}, {'value': '-1.05', 'spread': '0.598', 'groupId': 'OG005'}, {'value': '-1.28', 'spread': '0.749', 'groupId': 'OG006'}, {'value': '-2.17', 'spread': '0.252', 'groupId': 'OG007'}, {'value': '-0.06', 'spread': '0.092', 'groupId': 'OG008'}, {'value': '-1.77', 'spread': '0.931', 'groupId': 'OG009'}, {'value': '-1.83', 'spread': '0.219', 'groupId': 'OG010'}, {'value': '-0.09', 'spread': '0.039', 'groupId': 'OG011'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.400', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.503', 'groupId': 'OG001'}, {'value': '-1.51', 'spread': '0.245', 'groupId': 'OG002'}, {'value': '-1.69', 'spread': '0.766', 'groupId': 'OG003'}, {'value': '0.02', 'spread': '0.039', 'groupId': 'OG004'}, {'value': '-0.30', 'spread': '0.382', 'groupId': 'OG005'}, {'value': '-0.16', 'spread': '0.175', 'groupId': 'OG006'}, {'value': '-1.43', 'spread': '0.711', 'groupId': 'OG007'}, {'value': '-0.01', 'spread': '0.129', 'groupId': 'OG008'}, {'value': '-0.48', 'spread': '0.608', 'groupId': 'OG009'}, {'value': '-0.37', 'spread': '0.368', 'groupId': 'OG010'}, {'value': '-0.00', 'spread': '0.016', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'HBsAg reductions at nadir and Week 4', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part D: HBV Participants Placebo', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous'}], 'classes': [{'title': 'Nadir', 'categories': [{'measurements': [{'value': '-1.44', 'spread': '0.998', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '1.007', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.917', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '1.195', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.472', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'HBV DNA reductions at nadir and Week 4', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Titers (if Applicable) of ADA to VIR-3434', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'OG004', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}, {'id': 'OG005', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'OG006', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG007', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG008', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG009', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'OG010', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG011', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG012', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'OG013', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '40'}, {'value': '160', 'groupId': 'OG002', 'lowerLimit': '160', 'upperLimit': '160'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '40', 'groupId': 'OG006', 'lowerLimit': '40', 'upperLimit': '40'}, {'value': '80', 'groupId': 'OG007', 'lowerLimit': '40', 'upperLimit': '160'}, {'value': '240', 'groupId': 'OG008', 'lowerLimit': '20', 'upperLimit': '1280'}, {'value': '120', 'groupId': 'OG009', 'lowerLimit': '80', 'upperLimit': '160'}, {'value': '80', 'groupId': 'OG010', 'lowerLimit': '80', 'upperLimit': '80'}, {'value': '20', 'groupId': 'OG011', 'lowerLimit': '19', 'upperLimit': '40'}, {'value': '40', 'groupId': 'OG012', 'lowerLimit': '20', 'upperLimit': '2560'}, {'value': '20', 'groupId': 'OG013', 'lowerLimit': '20', 'upperLimit': '320'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose', 'description': 'Evaluate the immunogenicity of VIR-3434', 'unitOfMeasure': 'Median Titer', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity Analysis Set'}, {'type': 'SECONDARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'OG004', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}], 'classes': [{'categories': [{'measurements': [{'value': '9.46', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '32.1', 'spread': '18.0', 'groupId': 'OG001'}, {'value': '105', 'spread': '23.7', 'groupId': 'OG002'}, {'value': '363', 'spread': '32.6', 'groupId': 'OG003'}, {'value': '1060', 'spread': '20.00', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose', 'description': 'VIR-3434 Maximum Concentration in Serum', 'unitOfMeasure': 'Part A: μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set'}, {'type': 'SECONDARY', 'title': 'AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'OG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'OG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'OG003', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'OG004', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}], 'classes': [{'categories': [{'measurements': [{'value': '302', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '964', 'spread': '22.6', 'groupId': 'OG001'}, {'value': '3060', 'spread': '19.8', 'groupId': 'OG002'}, {'value': '4010', 'spread': '28.5', 'groupId': 'OG003'}, {'value': '12300', 'spread': '19.7', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose', 'description': 'VIR-3434 under the curve from time 0 to last measurable Time', 'unitOfMeasure': 'Part A: day*µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with BQL at all time points were excluded from the PK analysis, hence for different n in the cohorts. AUClast was only calculated if the PK parameter was estimated in at least 3 subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'FG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'FG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'FG003', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'FG004', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}, {'id': 'FG005', 'title': 'Part A Healthy Participants Placebo', 'description': 'Healthy participants received placebo subcutaneously or intravenously'}, {'id': 'FG006', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'FG007', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'FG008', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'FG009', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'FG010', 'title': 'Part B: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received placebo subcutaneous'}, {'id': 'FG011', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'FG012', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'FG013', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'FG014', 'title': 'Part C: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received placebo subcutaneous'}, {'id': 'FG015', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'FG016', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}, {'id': 'FG017', 'title': 'Part D: HBV Participants Placebo', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '8'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '6'}, {'groupId': 'FG013', 'numSubjects': '6'}, {'groupId': 'FG014', 'numSubjects': '6'}, {'groupId': 'FG015', 'numSubjects': '6'}, {'groupId': 'FG016', 'numSubjects': '6'}, {'groupId': 'FG017', 'numSubjects': '4'}]}, {'type': 'Entered Extended Follow Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '3'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '8'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '6'}, {'groupId': 'FG013', 'numSubjects': '4'}, {'groupId': 'FG014', 'numSubjects': '6'}, {'groupId': 'FG015', 'numSubjects': '6'}, {'groupId': 'FG016', 'numSubjects': '6'}, {'groupId': 'FG017', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '6', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '113', 'groupId': 'BG018'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Healthy Participants 90 mg SC', 'description': 'Healthy participants received 90 mg VIR-3434 subcutaneous'}, {'id': 'BG001', 'title': 'Part A Healthy Participants 300 mg SC', 'description': 'Healthy participants received 300 mg VIR-3434 subcutaneous'}, {'id': 'BG002', 'title': 'Part A Healthy Participants 900 mg SC', 'description': 'Healthy participants received 900 mg VIR-3434 subcutaneous'}, {'id': 'BG003', 'title': 'Part A Healthy Participants 900 mg IV', 'description': 'Healthy Participants received 900 mg VIR-3434 intravenously'}, {'id': 'BG004', 'title': 'Part A: Healthy Participants 3000 mg IV', 'description': 'Healthy participants received 3000 mg VIR-3434 intravenously'}, {'id': 'BG005', 'title': 'Part A Healthy Participants Placebo', 'description': 'Healthy participants received placebo subcutaneously or intravenously'}, {'id': 'BG006', 'title': 'Part B: HBV Participants 6 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 6 mg VIR-3434 subcutaneous'}, {'id': 'BG007', 'title': 'Part B: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\<3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'BG008', 'title': 'Part B: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'BG009', 'title': 'Part B: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'BG010', 'title': 'Part B: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\<3000 IU/mL received placebo subcutaneous'}, {'id': 'BG011', 'title': 'Part C: HBV Participants 18 mg SC', 'description': 'HBV Participants on NRTI therapy with HBsAg \\>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous'}, {'id': 'BG012', 'title': 'Part C: HBV Participants 75 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous'}, {'id': 'BG013', 'title': 'Part C: HBV Participants 300 mg SC', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous'}, {'id': 'BG014', 'title': 'Part C: HBV Participants Placebo', 'description': 'HBV Participants on NRTI Therapy with HBsAg \\>/= 3000 IU/mL received placebo subcutaneous'}, {'id': 'BG015', 'title': 'Part D: HBV Participants 75 mg SC', 'description': 'HBV Participants not on NRTI therapy with HBV DNA \\>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous'}, {'id': 'BG016', 'title': 'Part D: HBV Participants 300 mg SC', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous'}, {'id': 'BG017', 'title': 'Part D: HBV Participants Placebo', 'description': 'HBV Participants not on NRTI Therapy with HBV DNA \\>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous'}, {'id': 'BG018', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '6', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '113', 'groupId': 'BG018'}]}], 'categories': [{'measurements': [{'value': '31.3', 'spread': '11.94', 'groupId': 'BG000'}, {'value': '27.7', 'spread': '7.92', 'groupId': 'BG001'}, {'value': '31.5', 'spread': '9.77', 'groupId': 'BG002'}, {'value': '24.8', 'spread': '4.58', 'groupId': 'BG003'}, {'value': '29.3', 'spread': '12.99', 'groupId': 'BG004'}, {'value': '30.3', 'spread': '10.77', 'groupId': 'BG005'}, {'value': '56.3', 'spread': '5.72', 'groupId': 'BG006'}, {'value': '49.0', 'spread': '6.93', 'groupId': 'BG007'}, {'value': '50.8', 'spread': '8.35', 'groupId': 'BG008'}, {'value': '50.0', 'spread': '8.81', 'groupId': 'BG009'}, {'value': '51.6', 'spread': '6.35', 'groupId': 'BG010'}, {'value': '44.5', 'spread': '10.82', 'groupId': 'BG011'}, {'value': '38.2', 'spread': '8.33', 'groupId': 'BG012'}, {'value': '38.8', 'spread': '8.95', 'groupId': 'BG013'}, {'value': '44.0', 'spread': '8.53', 'groupId': 'BG014'}, {'value': '42.7', 'spread': '7.71', 'groupId': 'BG015'}, {'value': '38.0', 'spread': '6.16', 'groupId': 'BG016'}, {'value': '37.3', 'spread': '8.54', 'groupId': 'BG017'}, {'value': '39.6', 'spread': '12.37', 'groupId': 'BG018'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '6', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '113', 'groupId': 'BG018'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '4', 'groupId': 'BG015'}, {'value': '3', 'groupId': 'BG016'}, {'value': '2', 'groupId': 'BG017'}, {'value': '49', 'groupId': 'BG018'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '3', 'groupId': 'BG016'}, {'value': '2', 'groupId': 'BG017'}, {'value': '64', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '6', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '113', 'groupId': 'BG018'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '4', 'groupId': 'BG018'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '5', 'groupId': 'BG013'}, {'value': '5', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '97', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '12', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '6', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '113', 'groupId': 'BG018'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '5', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '36', 'groupId': 'BG018'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '1', 'groupId': 'BG017'}, {'value': '6', 'groupId': 'BG018'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '6', 'groupId': 'BG018'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '6', 'groupId': 'BG013'}, {'value': '2', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '3', 'groupId': 'BG016'}, {'value': '2', 'groupId': 'BG017'}, {'value': '51', 'groupId': 'BG018'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '1', 'groupId': 'BG017'}, {'value': '14', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline HbsAg (IU/mL)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '6', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG016'}, {'value': '4', 'groupId': 'BG017'}, {'value': '72', 'groupId': 'BG018'}]}], 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.617', 'groupId': 'BG006'}, {'value': '2.78', 'spread': '0.711', 'groupId': 'BG007'}, {'value': '2.55', 'spread': '0.693', 'groupId': 'BG008'}, {'value': '2.59', 'spread': '1.150', 'groupId': 'BG009'}, {'value': '2.24', 'spread': '0.638', 'groupId': 'BG010'}, {'value': '3.34', 'spread': '0.455', 'groupId': 'BG011'}, {'value': '4.12', 'spread': '0.353', 'groupId': 'BG012'}, {'value': '3.71', 'spread': '0.375', 'groupId': 'BG013'}, {'value': '3.18', 'spread': '1.652', 'groupId': 'BG014'}, {'value': '3.79', 'spread': '0.729', 'groupId': 'BG015'}, {'value': '4.29', 'spread': '0.305', 'groupId': 'BG016'}, {'value': '4.15', 'spread': '0.496', 'groupId': 'BG017'}, {'value': '3.17', 'spread': '1.05', 'groupId': 'BG018'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log 10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-20', 'size': 1094965, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-20T11:34', 'hasProtocol': True}, {'date': '2023-03-27', 'size': 608249, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-20T11:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2020-05-25', 'resultsFirstSubmitDate': '2023-10-20', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-27', 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'Up to 280 days post-dose'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 Maximum Concentration in Serum'}, {'measure': 'Tmax', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 time of Cmax in Serum'}, {'measure': 'AUClast', 'timeFrame': 'Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 under the curve from time 0 to last measurable Time'}, {'measure': 't1/2', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 apparent Elimination Half-life (t1/2) in serum'}, {'measure': 'Vz/F', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 Volume of Distribution (SC only)'}, {'measure': 'Vz', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose', 'description': 'VIR-3434 Volume of Distribution (IV only)'}, {'measure': 'CL/F', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'VIR-3434 Apparent serum clearance (SC only)'}, {'measure': 'CL', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose', 'description': 'VIR-3434 Apparent serum clearance (IV only)'}, {'measure': 'Number of Participants With ADA to VIR-3434', 'timeFrame': 'Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose', 'description': 'Evaluate the immunogenicity of VIR-3434'}, {'measure': 'Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)', 'timeFrame': 'Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'HBsAg reductions at nadir and Week 4'}, {'measure': 'Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)', 'timeFrame': 'Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose', 'description': 'HBV DNA reductions at nadir and Week 4'}, {'measure': 'Titers (if Applicable) of ADA to VIR-3434', 'timeFrame': 'Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose', 'description': 'Evaluate the immunogenicity of VIR-3434'}, {'measure': 'Cmax', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose', 'description': 'VIR-3434 Maximum Concentration in Serum'}, {'measure': 'AUClast', 'timeFrame': 'Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose', 'description': 'VIR-3434 under the curve from time 0 to last measurable Time'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B Virus', 'Chronic Hepatitis B', 'HBV', 'Hepatitis'], 'conditions': ['Chronic Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '40882923', 'type': 'DERIVED', 'citation': 'Vincenzetti L, Wong R, Marzi R, Guarino B, Stefanutti E, Gupta SV, Rosen LE, Belnap DM, Wang L, Chen YP, di Iulio J, Momin A, Tracy KE, Deshpande S, Errico JM, Giovannoni F, Sprugasci N, Peter A, Seu L, Cloutier D, Tay CH, Snell G, Czudnochowski N, Lempp FA, Havenar-Daughton C, Benigni F, Lanzavecchia A, Agarwal K, Yuen MF, Wedemeyer H, Gane E, Arvin A, Corti D, Schmid MA. Engineered monoclonal antibody tobevibart enhances HBsAg capture by Fc receptor-positive cells and activates HBV-specific T cells. J Hepatol. 2025 Aug 27:S0168-8278(25)02452-3. doi: 10.1016/j.jhep.2025.08.016. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 study in which healthy volunteers and participants with chronic HBV infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability, pharmacokinetics (PK), and antiviral activity (only in participants with chronic HBV infection).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy Volunteers:\n\nInclusion Criteria:\n\n* Male or female age 18 - 55\n* Weight 40-125 kg\n\nExclusion Criteria:\n\n* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation\n* History or evidence of drug or alcohol abuse\n* History of allergic reactions to monoclonal antibodies or antibody fragments\n* History of anaphylaxis\n\nCHB Patients:\n\nInclusion Criteria:\n\n* Male or female age 18 - 65\n* Weight 40-125 kg\n* Chronic HBV infection for \\>/= 6 months\n\nExclusion Criteria:\n\n* Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation\n* Significant fibrosis or cirrhosis\n* History or evidence of drug or alcohol abuse\n* History of chronic liver disease from any cause other than chronic HBV infection\n* History of hepatic decompensation\n* History of anaphylaxis\n* History of allergic reactions to monoclonal antibodies or antibody fragments\n* History of immune complex disease\n* Active infection with HIV, HCV or hepatitis Delta virus'}, 'identificationModule': {'nctId': 'NCT04423393', 'briefTitle': 'Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vir Biotechnology, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434', 'orgStudyIdInfo': {'id': 'VIR-3434-1002'}, 'secondaryIdInfos': [{'id': '2019-003837-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIR-3434', 'interventionNames': ['Biological: VIR-3434']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'VIR-3434', 'type': 'BIOLOGICAL', 'description': 'VIR-3434 given by subcutaneous injection or intravenous infusion.', 'armGroupLabels': ['VIR-3434']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Investigative Site', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '1010', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Investigative Site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '4130', 'city': 'Havelock North', 'country': 'New Zealand', 'facility': 'Investigative Site', 'geoPoint': {'lat': -39.66667, 'lon': 176.88333}}, {'zip': '6021', 'city': 'Newtown', 'country': 'New Zealand', 'facility': 'Investigative Site', 'geoPoint': {'lat': -41.31115, 'lon': 174.77935}}, {'zip': '3110', 'city': 'Tauranga', 'country': 'New Zealand', 'facility': 'Investigative Site', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Investigative Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '47392', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Investigative Site', 'geoPoint': {'lat': 35.10168, 'lon': 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51.50853, 'lon': -0.12574}}, {'zip': 'M8 5RB', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Investigative Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vir Biotechnology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}