Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT02061358
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2014-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003715', 'term': 'Dengue'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctgov@ebsi.com', 'title': 'Clinical Development Representative', 'organization': 'Emergent BioSolutions'}, 'certainAgreement': {'otherDetails': 'The Sponsor will make the results of the study publicly available, including for purposes of national and international registration, publication, and information for medical and pharmaceutical professionals.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From time of the first dose administration through 9 ± 1 days after dosing', 'description': 'Adverse events were coded by the Medical Dictionary for Regulatory Activities (MedDRA) according to system organ class (SOC) and preferred term (PT).', 'eventGroups': [{'id': 'EG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Placebo', 'description': 'Placebo oral, single dose', 'otherNumAtRisk': 16, 'otherNumAffected': 12, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chemical eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'APTT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'ALT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'AST increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 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'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group', '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': '16', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}, {'id': 'OG008', 'title': 'Placebo', 'description': 'Placebo oral, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of the first dose administration through Day 9 ± 1', 'description': 'TEAEs are those AEs occurring only after administration of investigational product', 'unitOfMeasure': 'Subjects with at least 1 TEAE', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all subjects who received any investigational product, UV-4B or placebo'}, {'type': 'PRIMARY', 'title': 'Subjects With Serious Adverse Event (SAEs) by Treatment Group', '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': '16', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}, {'id': 'OG008', 'title': 'Placebo', 'description': 'Placebo oral, single dose'}], 'classes': [{'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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of the first dose administration through Day 9 ± 1', 'description': 'Subjects with AEs considered serious by the investigator', 'unitOfMeasure': 'Subjects with at least 1 SAE', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all subjects who received any investigational product, UV-4B or placebo'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)', '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': '16', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}, {'id': 'OG008', 'title': 'Placebo', 'description': 'Placebo oral, single dose'}], 'classes': [{'title': 'Subjects with any Grade 1 or higher', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}]}]}, {'title': 'Supine systolic BP ≤ 89 mmHg', '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': '2', 'groupId': 'OG008'}]}]}, {'title': 'Supine systolic BP ≥ 141 mmHg', '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': '1', 'groupId': 'OG008'}]}]}, {'title': 'Standing systolic BP ≤ 89 mmHg', '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': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Standing systolic BP ≥ 141 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Supine diastolic BP ≥ 91 mmHg', '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'}]}]}, {'title': 'Standing diastolic BP ≥ 91 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}, {'title': 'Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}]}, {'title': 'Supine pulse ≤ 54 bpm, baseline > 60 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Supine pulse ≥ 101 bpm', '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': '1', 'groupId': 'OG008'}]}]}, {'title': 'Standing pulse ≤ 50 bpm, baseline ≤ 60 bpm)', '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'}]}]}, {'title': 'Standing pulse ≤ 54 bpm, baseline > 60 bpm', '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': '1', 'groupId': 'OG008'}]}]}, {'title': 'Standing pulse ≥ 101 bpm', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}]}]}, {'title': 'Respiratory rate ≥ 17 breaths/min', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}]}, {'title': 'Temperature ≥ 100.4 ⁰F (38.0 ⁰C)', '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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of the first dose administration through Day 9 ± 1', 'description': 'Number of subjects in a treatment group, who had a vital sign value of toxicity Grade 1 or higher: supine and standing systolic blood pressure (BP), supine and standing diastolic BP, supine and standing pulse rate, respiratory rate, and temperature', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all subjects who received any investigational product, UV-4B or placebo'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group', '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': '16', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}, {'id': 'OG008', 'title': 'Placebo', 'description': 'Placebo oral, single dose'}], 'classes': [{'title': 'Subjects with an outlier value', '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'}]}]}, {'title': 'QTcF > 450 ms (males) or > 470 ms (females)', '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'}]}]}, {'title': 'QTcF > 500 ms', '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'}]}]}, {'title': 'QTcF increase from baseline > 30 ms or ≤ 60 ms', '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'}]}]}, {'title': 'QTcF increase from baseline > 220 ms', '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'}]}]}, {'title': 'PR > 220 ms', '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'}]}]}, {'title': 'QRS > 120 ms', '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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of the first dose administration through Day 9 ± 1', 'description': "Number of subjects in a treatment group with outlier ECG findings: QTcF (Fridericia's), PR, and QRS intervals", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all subjects who received any investigational product, UV-4B or placebo'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group', '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': '16', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}, {'id': 'OG008', 'title': 'Placebo', 'description': 'Placebo oral, single dose'}], 'classes': [{'title': 'Hemoglobin ≤ 11.5 (♀), 13.5 (♂) g/dL or any ↓', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}]}]}, {'title': 'WBC ≥ 10,800 or ≤ 3,500 cell/mm^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': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Neutrophils ≤ 2,000 cell/mm^3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Lymphocytes ≤ 1,000 cell/mm^3', 'categories': [{'measurements': [{'value': '1', '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'}]}]}, {'title': 'Eosinophils ≥ 650 cell/mm^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': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Prothrombin time ≥ 1 * ULN', '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': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Activated partial thromboplastin time ≥ 1 * ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Alkaline phosphatase ≥ 2 * ULN', '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'}]}]}, {'title': 'Alanine aminotransferase ≥ 1.1 * ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Aspartate aminotransferase ≥ 1.1 * ULN', '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': '1', 'groupId': 'OG008'}]}]}, {'title': 'Bilirubin ≥ 1.1 * ULN', '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'}]}]}, {'title': 'Calcium ≤ 8.8 or ≥ 10.6 mg/dL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Magnesium ≤ 1.7 mg/dL', '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'}]}]}, {'title': 'Phosphorous ≤ 2.5 mg/dL', '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': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Potassium ≤ 3.5 or ≥ 5.3 mEq/L', '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': '2', 'groupId': 'OG008'}]}]}, {'title': 'Sodium ≤ 134 or ≥ 148 mEq/L', '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'}]}]}, {'title': 'Albumin ≤ 3.3 g/dL', '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'}]}]}, {'title': 'Total protein ≤ 5.9 g/dL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Blood urea nitrogen ≥ 21 mg/dL', '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'}]}]}, {'title': 'Creatinine ≥ 1.5 mg/dL', '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'}]}]}, {'title': 'Glucose ≤ 69 or ≥100 (fasting)/111 (random) mg/dL', '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': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Creatine phosphokinase ≥ 2 * ULN', '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': '1', 'groupId': 'OG008'}]}]}, {'title': 'Amylase ≥ 1.5 * ULN', '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'}]}]}, {'title': 'Lipase ≥ 1.5 * ULN', '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'}]}]}, {'title': 'Urine glucose trace or more', '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'}]}]}, {'title': 'Urine protein trace or more', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Urine red blood cell count ≥ 1 rbc/hpf', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 9 ± 1', 'description': 'Number of subjects with Grade 1 toxicity or higher for hematology, coagulation, chemistry and urinalysis analytes. ULN=upper limit of normal; WBC=white blood cell count.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all subjects who received any investigational product, UV-4B or placebo'}, {'type': 'SECONDARY', 'title': 'Cmax by Treatment Group: UV-4', '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'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '82.6', 'spread': '24.2', 'groupId': 'OG001'}, {'value': '289', 'spread': '17.5', 'groupId': 'OG002'}, {'value': '900', 'spread': '35.3', 'groupId': 'OG003'}, {'value': '2060', 'spread': '33.6', 'groupId': 'OG004'}, {'value': '4490', 'spread': '20.0', 'groupId': 'OG005'}, {'value': '9760', 'spread': '20.0', 'groupId': 'OG006'}, {'value': '13000', 'spread': '15.6', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'Cmax is the maximum plasma concentration, obtained directly from the observed concentration versus time data.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.'}, {'type': 'SECONDARY', 'title': 'Tmax by Treatment Group: UV-4', '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'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.0'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '1.50'}, {'value': '0.50', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '1.00'}, {'value': '0.50', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '1.52'}, {'value': '0.75', 'groupId': 'OG004', 'lowerLimit': '0.50', 'upperLimit': '1.00'}, {'value': '0.50', 'groupId': 'OG005', 'lowerLimit': '0.50', 'upperLimit': '1.00'}, {'value': '0.75', 'groupId': 'OG006', 'lowerLimit': '0.50', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG007', 'lowerLimit': '0.50', 'upperLimit': '1.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'Tmax is the time of maximum concentration observed directly from the observed concentration versus time data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.'}, {'type': 'SECONDARY', 'title': 'AUC(0-last) by Treatment Group: UV-4', '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'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '82.1', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '406', 'spread': '24.7', 'groupId': 'OG001'}, {'value': '1230', 'spread': '10.9', 'groupId': 'OG002'}, {'value': '3640', 'spread': '12.7', 'groupId': 'OG003'}, {'value': '7050', 'spread': '8.3', 'groupId': 'OG004'}, {'value': '13600', 'spread': '14.6', 'groupId': 'OG005'}, {'value': '32700', 'spread': '10.9', 'groupId': 'OG006'}, {'value': '42700', 'spread': '13.2', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'AUC(0-last) is the area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration, calculated by linear up/log down trapezoidal summation.', 'unitOfMeasure': 'ng * h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.'}, {'type': 'SECONDARY', 'title': 'AUC(0-inf) by Treatment Group: UV-4', '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'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '94.6', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '420', 'spread': '24.2', 'groupId': 'OG001'}, {'value': '1260', 'spread': '10.2', 'groupId': 'OG002'}, {'value': '3700', 'spread': '13.3', 'groupId': 'OG003'}, {'value': '7090', 'spread': '8.2', 'groupId': 'OG004'}, {'value': '13700', 'spread': '14.6', 'groupId': 'OG005'}, {'value': '32800', 'spread': '10.9', 'groupId': 'OG006'}, {'value': '42800', 'spread': '13.3', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'AUC(0-inf) is the area under the concentration-time curve in the sample from pre-dose extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant: AUC(0-last) - C(last)/λ(z).', 'unitOfMeasure': 'ng * h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.'}, {'type': 'SECONDARY', 'title': 'CL/F by Treatment Group: UV-4', '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'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '24.1', 'groupId': 'OG001'}, {'value': '23.9', 'spread': '10.5', 'groupId': 'OG002'}, {'value': '24.3', 'spread': '13.5', 'groupId': 'OG003'}, {'value': '25.4', 'spread': '8.2', 'groupId': 'OG004'}, {'value': '26.3', 'spread': '14.7', 'groupId': 'OG005'}, {'value': '22.0', 'spread': '11.0', 'groupId': 'OG006'}, {'value': '23.4', 'spread': '13.3', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'CL/F is the apparent systematic clearance, calculated as dose (free-base equivalent) divided by AUC(0-inf).', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.'}, {'type': 'SECONDARY', 'title': 'Vz/F by Treatment Group: UV-4', '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'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '470', 'spread': '32.8', 'groupId': 'OG000'}, {'value': '409', 'spread': '30.6', 'groupId': 'OG001'}, {'value': '344', 'spread': '16.7', 'groupId': 'OG002'}, {'value': '358', 'spread': '21.5', 'groupId': 'OG003'}, {'value': '317', 'spread': '17.2', 'groupId': 'OG004'}, {'value': '308', 'spread': '11.9', 'groupId': 'OG005'}, {'value': '259', 'spread': '10.3', 'groupId': 'OG006'}, {'value': '290', 'spread': '27.3', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'Vz/F is the apparent volume of distribution of UV-4 based on the terminal phase, calculated as dose (free-base equivalent) divided by \\[λ(z) × AUC(0-inf)\\].', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.'}, {'type': 'SECONDARY', 'title': 't(1/2) by Treatment Group: UV-4', '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'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '9.11', 'groupId': 'OG000', 'lowerLimit': '7.75', 'upperLimit': '16.3'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '13.7'}, {'value': '9.98', 'groupId': 'OG002', 'lowerLimit': '8.75', 'upperLimit': '10.8'}, {'value': '9.56', 'groupId': 'OG003', 'lowerLimit': '8.52', 'upperLimit': '16.0'}, {'value': '8.52', 'groupId': 'OG004', 'lowerLimit': '7.65', 'upperLimit': '10.3'}, {'value': '8.14', 'groupId': 'OG005', 'lowerLimit': '7.06', 'upperLimit': '9.08'}, {'value': '8.03', 'groupId': 'OG006', 'lowerLimit': '7.66', 'upperLimit': '9.23'}, {'value': '7.95', 'groupId': 'OG007', 'lowerLimit': '6.60', 'upperLimit': '13.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 't(1/2) is the apparent terminal half-life, determined as ln(2)/λ(z).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.'}, {'type': 'SECONDARY', 'title': 'Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group', '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'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}], 'classes': [{'title': 'Ae(0-6)', 'categories': [{'measurements': [{'value': '0.607', 'spread': '0.145', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '0.386', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '1.18', 'groupId': 'OG002'}, {'value': '38.1', 'spread': '3.83', 'groupId': 'OG003'}, {'value': '77.5', 'spread': '3.49', 'groupId': 'OG004'}, {'value': '159', 'spread': '24.3', 'groupId': 'OG005'}, {'value': '301', 'spread': '36.3', 'groupId': 'OG006'}, {'value': '428', 'spread': '64.5', 'groupId': 'OG007'}]}]}, {'title': 'Ae(6-12)', 'categories': [{'measurements': [{'value': '0.215', 'spread': '0.0496', 'groupId': 'OG000'}, {'value': '0.859', 'spread': '0.112', 'groupId': 'OG001'}, {'value': '2.45', 'spread': '0.145', 'groupId': 'OG002'}, {'value': '6.05', 'spread': '2.55', 'groupId': 'OG003'}, {'value': '12.1', 'spread': '1.48', 'groupId': 'OG004'}, {'value': '19.1', 'spread': '7.00', 'groupId': 'OG005'}, {'value': '42.5', 'spread': '6.00', 'groupId': 'OG006'}, {'value': '53.7', 'spread': '15.2', 'groupId': 'OG007'}]}]}, {'title': 'Ae(12-24)', 'categories': [{'measurements': [{'value': '0.202', 'spread': '0.0543', 'groupId': 'OG000'}, {'value': '0.608', 'spread': '0.0888', 'groupId': 'OG001'}, {'value': '1.61', 'spread': '0.363', 'groupId': 'OG002'}, {'value': '3.89', 'spread': '0.799', 'groupId': 'OG003'}, {'value': '6.06', 'spread': '2.40', 'groupId': 'OG004'}, {'value': '7.09', 'spread': '1.90', 'groupId': 'OG005'}, {'value': '11.7', 'spread': '1.60', 'groupId': 'OG006'}, {'value': '16.4', 'spread': '5.32', 'groupId': 'OG007'}]}]}, {'title': 'Ae(24-48)', 'categories': [{'measurements': [{'value': '0.170', 'spread': '0.0416', 'groupId': 'OG000'}, {'value': '0.503', 'spread': '0.0655', 'groupId': 'OG001'}, {'value': '0.887', 'spread': '0.200', 'groupId': 'OG002'}, {'value': '1.61', 'spread': '0.474', 'groupId': 'OG003'}, {'value': '2.43', 'spread': '1.03', 'groupId': 'OG004'}, {'value': '2.83', 'spread': '0.672', 'groupId': 'OG005'}, {'value': '4.09', 'spread': '1.24', 'groupId': 'OG006'}, {'value': '5.21', 'spread': '1.41', 'groupId': 'OG007'}]}]}, {'title': 'Ae(0-12)', 'categories': [{'measurements': [{'value': '0.822', 'spread': '0.177', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '0.428', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '1.31', 'groupId': 'OG002'}, {'value': '44.1', 'spread': '3.83', 'groupId': 'OG003'}, {'value': '89.6', 'spread': '3.76', 'groupId': 'OG004'}, {'value': '178', 'spread': '18.7', 'groupId': 'OG005'}, {'value': '355', 'spread': '34.6', 'groupId': 'OG006'}, {'value': '498', 'spread': '65.6', 'groupId': 'OG007'}]}]}, {'title': 'Ae(0-24)', 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.197', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '0.515', 'groupId': 'OG001'}, {'value': '14.6', 'spread': '1.13', 'groupId': 'OG002'}, {'value': '48.0', 'spread': '3.75', 'groupId': 'OG003'}, {'value': '95.7', 'spread': '4.26', 'groupId': 'OG004'}, {'value': '185', 'spread': '17.9', 'groupId': 'OG005'}, {'value': '355', 'spread': '34.6', 'groupId': 'OG006'}, {'value': '498', 'spread': '65.6', 'groupId': 'OG007'}]}]}, {'title': 'Ae(0-last)', 'categories': [{'measurements': [{'value': '1.19', 'spread': '0.200', 'groupId': 'OG000'}, {'value': '4.64', 'spread': '0.463', 'groupId': 'OG001'}, {'value': '15.5', 'spread': '0.982', 'groupId': 'OG002'}, {'value': '49.6', 'spread': '3.58', 'groupId': 'OG003'}, {'value': '97.9', 'spread': '4.86', 'groupId': 'OG004'}, {'value': '188', 'spread': '17.3', 'groupId': 'OG005'}, {'value': '360', 'spread': '34.7', 'groupId': 'OG006'}, {'value': '504', 'spread': '66.1', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose', 'description': 'Ae is the by-interval and cumulative amounts of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. Ae by-interval amounts were calculated as the product of urine volume and urine concentration. Ae(0-last) is the cumulative amount of UV-4 drug excreted in urine over the entire collection period, 48 hours. Cumulative amounts were calculated as the summation of the amounts excreted in collection intervals.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.'}, {'type': 'SECONDARY', 'title': 'Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group', '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'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}], 'classes': [{'title': 'fe(0-6)', 'categories': [{'measurements': [{'value': '20.2', 'spread': '4.81', 'groupId': 'OG000'}, {'value': '26.7', 'spread': '3.86', 'groupId': 'OG001'}, {'value': '35.3', 'spread': '3.84', 'groupId': 'OG002'}, {'value': '42.2', 'spread': '4.26', 'groupId': 'OG003'}, {'value': '43.0', 'spread': '1.96', 'groupId': 'OG004'}, {'value': '44.2', 'spread': '6.69', 'groupId': 'OG005'}, {'value': '41.8', 'spread': '5.04', 'groupId': 'OG006'}, {'value': '42.8', 'spread': '6.45', 'groupId': 'OG007'}]}]}, {'title': 'fe(6-12)', 'categories': [{'measurements': [{'value': '7.17', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '8.59', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '8.16', 'spread': '0.480', 'groupId': 'OG002'}, {'value': '6.72', 'spread': '2.83', 'groupId': 'OG003'}, {'value': '6.74', 'spread': '0.820', 'groupId': 'OG004'}, {'value': '5.32', 'spread': '1.94', 'groupId': 'OG005'}, {'value': '5.90', 'spread': '0.833', 'groupId': 'OG006'}, {'value': '5.37', 'spread': '1.52', 'groupId': 'OG007'}]}]}, {'title': 'fe(12-24)', 'categories': [{'measurements': [{'value': '6.71', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '6.08', 'spread': '0.888', 'groupId': 'OG001'}, {'value': '5.36', 'spread': '1.21', 'groupId': 'OG002'}, {'value': '4.32', 'spread': '0.886', 'groupId': 'OG003'}, {'value': '3.37', 'spread': '1.34', 'groupId': 'OG004'}, {'value': '1.97', 'spread': '0.532', 'groupId': 'OG005'}, {'value': '1.63', 'spread': '0.221', 'groupId': 'OG006'}, {'value': '1.64', 'spread': '0.532', 'groupId': 'OG007'}]}]}, {'title': 'fe(24-48)', 'categories': [{'measurements': [{'value': '5.66', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '5.03', 'spread': '0.655', 'groupId': 'OG001'}, {'value': '2.96', 'spread': '0.664', 'groupId': 'OG002'}, {'value': '1.79', 'spread': '0.528', 'groupId': 'OG003'}, {'value': '1.35', 'spread': '0.572', 'groupId': 'OG004'}, {'value': '0.787', 'spread': '0.186', 'groupId': 'OG005'}, {'value': '0.569', 'spread': '0.172', 'groupId': 'OG006'}, {'value': '0.521', 'spread': '0.141', 'groupId': 'OG007'}]}]}, {'title': 'fe(0-12)', 'categories': [{'measurements': [{'value': '27.4', 'spread': '5.93', 'groupId': 'OG000'}, {'value': '35.3', 'spread': '4.28', 'groupId': 'OG001'}, {'value': '43.4', 'spread': '4.28', 'groupId': 'OG002'}, {'value': '49.0', 'spread': '4.28', 'groupId': 'OG003'}, {'value': '49.8', 'spread': '2.08', 'groupId': 'OG004'}, {'value': '49.5', 'spread': '5.18', 'groupId': 'OG005'}, {'value': '47.7', 'spread': '4.86', 'groupId': 'OG006'}, {'value': '48.2', 'spread': '6.66', 'groupId': 'OG007'}]}]}, {'title': 'fe(0-24)', 'categories': [{'measurements': [{'value': '34.1', 'spread': '6.57', 'groupId': 'OG000'}, {'value': '41.3', 'spread': '5.15', 'groupId': 'OG001'}, {'value': '48.8', 'spread': '3.72', 'groupId': 'OG002'}, {'value': '53.3', 'spread': '4.14', 'groupId': 'OG003'}, {'value': '53.1', 'spread': '2.37', 'groupId': 'OG004'}, {'value': '51.5', 'spread': '4.97', 'groupId': 'OG005'}, {'value': '49.4', 'spread': '4.81', 'groupId': 'OG006'}, {'value': '49.8', 'spread': '6.56', 'groupId': 'OG007'}]}]}, {'title': 'fe(0-last)', 'categories': [{'measurements': [{'value': '39.8', 'spread': '6.66', 'groupId': 'OG000'}, {'value': '46.4', 'spread': '4.63', 'groupId': 'OG001'}, {'value': '51.7', 'spread': '3.27', 'groupId': 'OG002'}, {'value': '55.1', 'spread': '3.98', 'groupId': 'OG003'}, {'value': '54.5', 'spread': '2.76', 'groupId': 'OG004'}, {'value': '52.3', 'spread': '4.82', 'groupId': 'OG005'}, {'value': '49.9', 'spread': '4.84', 'groupId': 'OG006'}, {'value': '50.4', 'spread': '6.61', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose', 'description': 'fe is the by-interval percentage of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. fe = Ae/(UV-4B dose x 100). fe(0-12), fe(0-24) and fe(0-last) are the cumulative percentages of UV-4 drug excreted in urine over 24 hours and the entire collection period, respectively.', 'unitOfMeasure': 'percentage of dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.'}, {'type': 'SECONDARY', 'title': 'CLr by Treatment Group: UV-4', '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'}]}], 'groups': [{'id': 'OG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'OG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'OG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'OG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'OG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'OG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'OG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'OG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '26.9', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '10.1', 'groupId': 'OG002'}, {'value': '13.6', 'spread': '14.2', 'groupId': 'OG003'}, {'value': '13.9', 'spread': '12.4', 'groupId': 'OG004'}, {'value': '13.7', 'spread': '23.6', 'groupId': 'OG005'}, {'value': '10.9', 'spread': '17.6', 'groupId': 'OG006'}, {'value': '11.7', 'spread': '17.2', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'CLr is the renal clearance, calculated at Ae(0-last) divided by AUC(0-last).', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing.L/h'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'FG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'FG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'FG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'FG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'FG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'FG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'FG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}, {'id': 'FG008', 'title': 'Placebo', 'description': 'Placebo oral, single dose'}], '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': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '16'}]}, {'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': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '16'}]}, {'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': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a single center study performed in the United States. The study was completed with a total of 64 patients enrolled.', 'preAssignmentDetails': "Each cohort was assigned 6 subjects who received the cohort's prescribed dose of UV-4B, along with 2 subjects in each cohort assigned to receive placebo."}, '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': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '64', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': '3 mg UV-4B', 'description': 'UV-4B 3 mg oral, single dose'}, {'id': 'BG001', 'title': '10 mg UV-4B', 'description': 'UV-4B 10 mg oral, single dose'}, {'id': 'BG002', 'title': '30 mg UV-4B', 'description': 'UV-4B 30 mg oral, single dose'}, {'id': 'BG003', 'title': '90 mg UV-4B', 'description': 'UV-4B 90 mg oral, single dose'}, {'id': 'BG004', 'title': '180 mg UV-4B', 'description': 'UV-4B 180 mg oral, single dose'}, {'id': 'BG005', 'title': '360 mg UV-4B', 'description': 'UV-4B 360 mg oral, single dose'}, {'id': 'BG006', 'title': '720 mg UV-4B', 'description': 'UV-4B 720 mg oral, single dose'}, {'id': 'BG007', 'title': '1000 mg UV-4B', 'description': 'UV-4B 1000 mg oral, single dose'}, {'id': 'BG008', 'title': 'Placebo', 'description': 'Placebo oral, single dose'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '5', 'groupId': 'BG000'}, {'value': '27', 'spread': '8', 'groupId': 'BG001'}, {'value': '27', 'spread': '4', 'groupId': 'BG002'}, {'value': '28', 'spread': '9', 'groupId': 'BG003'}, {'value': '28', 'spread': '9', 'groupId': 'BG004'}, {'value': '29', 'spread': '9', 'groupId': 'BG005'}, {'value': '25', 'spread': '9', 'groupId': 'BG006'}, {'value': '27', 'spread': '8', 'groupId': 'BG007'}, {'value': '28', 'spread': '8', 'groupId': 'BG008'}, {'value': '27', 'spread': '7', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '17', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '47', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}, {'value': '55', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', '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': '1', 'groupId': 'BG009'}]}, {'title': 'Asian', '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'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', '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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}, {'value': '51', 'groupId': 'BG009'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '173.4', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '171.8', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '175.0', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '175.2', 'spread': '3.8', 'groupId': 'BG003'}, {'value': '176.2', 'spread': '9.9', 'groupId': 'BG004'}, {'value': '174.8', 'spread': '8.9', 'groupId': 'BG005'}, {'value': '172.6', 'spread': '8.2', 'groupId': 'BG006'}, {'value': '173.5', 'spread': '3.2', 'groupId': 'BG007'}, {'value': '174.9', 'spread': '8.1', 'groupId': 'BG008'}, {'value': '174.25', 'spread': '8.39', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '82.9', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '79.6', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '80.8', 'spread': '9.7', 'groupId': 'BG002'}, {'value': '75.9', 'spread': '8.3', 'groupId': 'BG003'}, {'value': '84.0', 'spread': '8.5', 'groupId': 'BG004'}, {'value': '80.1', 'spread': '10.5', 'groupId': 'BG005'}, {'value': '74.1', 'spread': '11', 'groupId': 'BG006'}, {'value': '75.0', 'spread': '5.5', 'groupId': 'BG007'}, {'value': '76.2', 'spread': '11.5', 'groupId': 'BG008'}, {'value': '78.36', 'spread': '10.4', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '27.44', 'spread': '1.28', 'groupId': 'BG000'}, {'value': '26.88', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '26.44', 'spread': '2.36', 'groupId': 'BG002'}, {'value': '24.76', 'spread': '2.71', 'groupId': 'BG003'}, {'value': '27.05', 'spread': '1.84', 'groupId': 'BG004'}, {'value': '26.13', 'spread': '2.07', 'groupId': 'BG005'}, {'value': '24.86', 'spread': '2.93', 'groupId': 'BG006'}, {'value': '24.93', 'spread': '1.6', 'groupId': 'BG007'}, {'value': '24.89', 'spread': '2.82', 'groupId': 'BG008'}, {'value': '25.77', 'spread': '2.47', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Total number of randomized subjects in each cohort'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2014-02-06', 'resultsFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2014-02-11', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-20', 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group', 'timeFrame': 'From time of the first dose administration through Day 9 ± 1', 'description': 'TEAEs are those AEs occurring only after administration of investigational product'}, {'measure': 'Subjects With Serious Adverse Event (SAEs) by Treatment Group', 'timeFrame': 'From time of the first dose administration through Day 9 ± 1', 'description': 'Subjects with AEs considered serious by the investigator'}, {'measure': 'Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)', 'timeFrame': 'From time of the first dose administration through Day 9 ± 1', 'description': 'Number of subjects in a treatment group, who had a vital sign value of toxicity Grade 1 or higher: supine and standing systolic blood pressure (BP), supine and standing diastolic BP, supine and standing pulse rate, respiratory rate, and temperature'}, {'measure': 'Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group', 'timeFrame': 'From time of the first dose administration through Day 9 ± 1', 'description': "Number of subjects in a treatment group with outlier ECG findings: QTcF (Fridericia's), PR, and QRS intervals"}, {'measure': 'Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group', 'timeFrame': 'Day 9 ± 1', 'description': 'Number of subjects with Grade 1 toxicity or higher for hematology, coagulation, chemistry and urinalysis analytes. ULN=upper limit of normal; WBC=white blood cell count.'}], 'secondaryOutcomes': [{'measure': 'Cmax by Treatment Group: UV-4', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'Cmax is the maximum plasma concentration, obtained directly from the observed concentration versus time data.'}, {'measure': 'Tmax by Treatment Group: UV-4', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'Tmax is the time of maximum concentration observed directly from the observed concentration versus time data.'}, {'measure': 'AUC(0-last) by Treatment Group: UV-4', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'AUC(0-last) is the area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration, calculated by linear up/log down trapezoidal summation.'}, {'measure': 'AUC(0-inf) by Treatment Group: UV-4', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'AUC(0-inf) is the area under the concentration-time curve in the sample from pre-dose extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant: AUC(0-last) - C(last)/λ(z).'}, {'measure': 'CL/F by Treatment Group: UV-4', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'CL/F is the apparent systematic clearance, calculated as dose (free-base equivalent) divided by AUC(0-inf).'}, {'measure': 'Vz/F by Treatment Group: UV-4', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'Vz/F is the apparent volume of distribution of UV-4 based on the terminal phase, calculated as dose (free-base equivalent) divided by \\[λ(z) × AUC(0-inf)\\].'}, {'measure': 't(1/2) by Treatment Group: UV-4', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 't(1/2) is the apparent terminal half-life, determined as ln(2)/λ(z).'}, {'measure': 'Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group', 'timeFrame': 'Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose', 'description': 'Ae is the by-interval and cumulative amounts of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. Ae by-interval amounts were calculated as the product of urine volume and urine concentration. Ae(0-last) is the cumulative amount of UV-4 drug excreted in urine over the entire collection period, 48 hours. Cumulative amounts were calculated as the summation of the amounts excreted in collection intervals.'}, {'measure': 'Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group', 'timeFrame': 'Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose', 'description': 'fe is the by-interval percentage of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. fe = Ae/(UV-4B dose x 100). fe(0-12), fe(0-24) and fe(0-last) are the cumulative percentages of UV-4 drug excreted in urine over 24 hours and the entire collection period, respectively.'}, {'measure': 'CLr by Treatment Group: UV-4', 'timeFrame': 'Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)', 'description': 'CLr is the renal clearance, calculated at Ae(0-last) divided by AUC(0-last).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dengue', 'Arbovirus Infections', 'Flaviviridae Infections', 'Flavivirus Infections', 'Hemorrhagic Fevers, Viral', 'RNA Virus Infections', 'Virus Diseases', 'Pharmaceutical Solutions', 'Pharmacologic Actions', 'Therapeutic Uses'], 'conditions': ['Viral Infection']}, 'referencesModule': {'references': [{'pmid': '35939501', 'type': 'DERIVED', 'citation': 'Callahan M, Treston AM, Lin G, Smith M, Kaufman B, Khaliq M, Evans DeWald L, Spurgers K, Warfield KL, Lowe P, Duchars M, Sampath A, Ramstedt U. Randomized single oral dose phase 1 study of safety, tolerability, and pharmacokinetics of Iminosugar UV-4 Hydrochloride (UV-4B) in healthy subjects. PLoS Negl Trop Dis. 2022 Aug 8;16(8):e0010636. doi: 10.1371/journal.pntd.0010636. eCollection 2022 Aug.'}], 'seeAlsoLinks': [{'url': 'http://www.niaid.nih.gov/topics/denguefever/Pages/default.aspx', 'label': 'Information on dengue fever'}]}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.', 'detailedDescription': 'The causative agent of dengue fever is Dengue Virus (DENV), a member of the flavivirus genus. There are four DENV serotypes. Infection with one serotype results in lifelong immunity against that serotype, but only limited short-term cross-protection from infection with the other serotypes. Immunity to one serotype has a downside as subsequent infections by other serotypes increase the risk of developing more severe forms of dengue, which includes the most lethal form of the disease, dengue hemorrhagic fever. Traditional epidemiologic and serologic-based estimates suggest a range of 50 to 100 million DENV infections per year distributed over 100 countries. Recent cartographic-based modeling studies suggest that up to 390 million of dengue infections per year, of which 96 million are associated with clinical symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* Women: non-pregnant, non-lactating; if of childbearing potential, on specified contraception measures during the study period\n* Men: using barrier contraception measures during the study period\n\nExclusion Criteria:\n\n* Health conditions\n* Taking prescription and non-prescription drugs (exceptions: acetaminophen, vitamins, hormonal birth control)'}, 'identificationModule': {'nctId': 'NCT02061358', 'acronym': 'UV', 'briefTitle': 'Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Emergent BioSolutions'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single-Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects', 'orgStudyIdInfo': {'id': 'DMID 13-0001'}, 'secondaryIdInfos': [{'id': 'KQA71264'}, {'id': 'UV-DEN-0001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - 3 mg UV-4B', 'description': 'Subjects receiving UV-4B 3 mg oral solution or placebo', 'interventionNames': ['Drug: UV-4B 3 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 - 10 mg UV-4B', 'description': 'Subjects receiving UV-4B 10 mg oral solution or placebo', 'interventionNames': ['Drug: UV-4B 10 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3- 30 mg UV-4B', 'description': 'Subjects receiving UV-4B 30 mg oral solution or placebo', 'interventionNames': ['Drug: UV-4B 30 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 - 90 mg UV-4B', 'description': 'Subjects receiving UV-4B 90 mg oral solution or placebo', 'interventionNames': ['Drug: UV-4B 90 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5 - 180 mg UV-4B', 'description': 'Subjects receiving UV-4B 180 mg oral solution or placebo', 'interventionNames': ['Drug: UV-4B 180 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6 - 360 mg UV-4B', 'description': 'Subjects receiving UV-4B 360 mg oral solution or placebo', 'interventionNames': ['Drug: UV-4B 360 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 7 - 720 mg UV-4B', 'description': 'Subjects receiving UV-4B 720 mg oral solution or placebo', 'interventionNames': ['Drug: UV-4B 720 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 8 - 1000 mg UV-4B', 'description': 'Subjects receiving UV-4B 1000 mg oral solution or placebo', 'interventionNames': ['Drug: UV-4B 1000 mg', 'Drug: Placebo']}], 'interventions': [{'name': 'UV-4B 3 mg', 'type': 'DRUG', 'description': 'Oral solution, single dose', 'armGroupLabels': ['Cohort 1 - 3 mg UV-4B']}, {'name': 'UV-4B 10 mg', 'type': 'DRUG', 'description': 'Oral solution, single dose', 'armGroupLabels': ['Cohort 2 - 10 mg UV-4B']}, {'name': 'UV-4B 30 mg', 'type': 'DRUG', 'description': 'Oral solution, single dose', 'armGroupLabels': ['Cohort 3- 30 mg UV-4B']}, {'name': 'UV-4B 90 mg', 'type': 'DRUG', 'description': 'Oral solution, single dose', 'armGroupLabels': ['Cohort 4 - 90 mg UV-4B']}, {'name': 'UV-4B 180 mg', 'type': 'DRUG', 'description': 'Oral solution, single dose', 'armGroupLabels': ['Cohort 5 - 180 mg UV-4B']}, {'name': 'UV-4B 360 mg', 'type': 'DRUG', 'description': 'Oral solution, single dose', 'armGroupLabels': ['Cohort 6 - 360 mg UV-4B']}, {'name': 'UV-4B 720 mg', 'type': 'DRUG', 'description': 'Oral solution, single dose', 'armGroupLabels': ['Cohort 7 - 720 mg UV-4B']}, {'name': 'UV-4B 1000 mg', 'type': 'DRUG', 'description': 'Oral solution, single dose', 'armGroupLabels': ['Cohort 8 - 1000 mg UV-4B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral solution, single dose', 'armGroupLabels': ['Cohort 1 - 3 mg UV-4B', 'Cohort 2 - 10 mg UV-4B', 'Cohort 3- 30 mg UV-4B', 'Cohort 4 - 90 mg UV-4B', 'Cohort 5 - 180 mg UV-4B', 'Cohort 6 - 360 mg UV-4B', 'Cohort 7 - 720 mg UV-4B', 'Cohort 8 - 1000 mg UV-4B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Quintiles, Inc', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Thomas Murtaugh, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Medical Research Director, Quintiles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emergent BioSolutions', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}, {'name': 'Unither Virology', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}