Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-01 @ 5:36 PM
Study NCT ID:
NCT04916795
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2021-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Tolerability Of Single Dose Vupanorsen In Healthy Chinese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723171', 'term': 'vupanorsen'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through day 90', 'eventGroups': [{'id': 'EG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Mesenteric panniculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC24h) for Vupanorsen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.649', 'spread': '35', 'groupId': 'OG000'}, {'value': '10.82', 'spread': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on day 1', 'description': 'AUC24h is the area under the concentration-time profile from time 0 to 24 hour post-dose', 'unitOfMeasure': 'microgram*hour per milliliter(mcg*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen pharmacokinetic (PK) parameters of primary interest.'}, {'type': 'PRIMARY', 'title': 'AUC From Time 0 to 48 Hours Post-dose (AUC48h) for Vupanorsen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.699', 'spread': '34', 'groupId': 'OG000'}, {'value': '10.91', 'spread': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post dose', 'description': 'AUC48h is the area under the plasma concentration-time profile from time zero to the quantifiable concentration 48 hours post-dose', 'unitOfMeasure': 'mcg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.'}, {'type': 'PRIMARY', 'title': 'AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Vupanorsen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.950', 'spread': '34', 'groupId': 'OG000'}, {'value': '11.76', 'spread': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)', 'unitOfMeasure': 'mcg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5879', 'spread': '62', 'groupId': 'OG000'}, {'value': '1.810', 'spread': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'Maximum plasma concentration observed from data', 'unitOfMeasure': 'microgram per milliliter (μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.'}, {'type': 'PRIMARY', 'title': 'AUC From Time 0 Extrapolated to Infinite Time (AUCinf) for Vupanorsen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.081', 'spread': '36', 'groupId': 'OG000'}, {'value': '11.91', 'spread': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'AUCinf is area under the plasma concentration-time profile from time zero extrapolated to infinite time', 'unitOfMeasure': 'mcg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.'}, {'type': 'PRIMARY', 'title': 'Time for Cmax (Tmax) for Vupanorsen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '3.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'Time for Cmax (Tmax) for vupanorsen', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.'}, {'type': 'PRIMARY', 'title': 'Terminal Elimination Half Life (t½) for Vupanorsen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '475.9', 'spread': '205.50', 'groupId': 'OG000'}, {'value': '465.2', 'spread': '131.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'terminal elimination half life (t½) for vupanorsen', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.'}, {'type': 'PRIMARY', 'title': 'Apparent Clearance (CL/F) for Vupanorsen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.60', 'spread': '36', 'groupId': 'OG000'}, {'value': '13.43', 'spread': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'Apparent clearance for vupanorsen', 'unitOfMeasure': 'liter per hour (L/hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.'}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution (Vz/F) for Vupanorsen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '12500', 'spread': '37', 'groupId': 'OG000'}, {'value': '8681', 'spread': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'Apparent volume of distribution for vupanorsen', 'unitOfMeasure': 'liter (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants enrolled and treated who had at least 1 of the vupanorsen PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'title': 'All-causality', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through day 90', 'description': 'Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Causality to study treatment was determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and who took at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through day 90', 'description': 'Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and who took at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Vital Sign Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through day 90', 'description': 'Vital sign data included blood pressure and pulse rate. Clinical significance was assessed by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and who took at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through day 90', 'description': 'Clinical significance of ECG data was assessed by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and who took at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'title': 'DAY2', 'categories': [{'measurements': [{'value': '-13.88', 'spread': '18.644', 'groupId': 'OG000'}, {'value': '-22.14', 'spread': '15.103', 'groupId': 'OG001'}]}]}, {'title': 'DAY3', 'categories': [{'measurements': [{'value': '-32.65', 'spread': '22.375', 'groupId': 'OG000'}, {'value': '-43.56', 'spread': '15.151', 'groupId': 'OG001'}]}]}, {'title': 'DAY8', 'categories': [{'measurements': [{'value': '-59.65', 'spread': '18.727', 'groupId': 'OG000'}, {'value': '-69.11', 'spread': '13.462', 'groupId': 'OG001'}]}]}, {'title': 'DAY15', 'categories': [{'measurements': [{'value': '-54.07', 'spread': '21.893', 'groupId': 'OG000'}, {'value': '-69.48', 'spread': '11.659', 'groupId': 'OG001'}]}]}, {'title': 'DAY30', 'categories': [{'measurements': [{'value': '-48.66', 'spread': '21.921', 'groupId': 'OG000'}, {'value': '-62.81', 'spread': '18.873', 'groupId': 'OG001'}]}]}, {'title': 'DAY60', 'categories': [{'measurements': [{'value': '-38.54', 'spread': '23.440', 'groupId': 'OG000'}, {'value': '-53.33', 'spread': '11.830', 'groupId': 'OG001'}]}]}, {'title': 'DAY90', 'categories': [{'measurements': [{'value': '-12.69', 'spread': '20.238', 'groupId': 'OG000'}, {'value': '-29.72', 'spread': '15.587', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percent changes from baseline in ANGPTL3 on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and treated who had at least 1 of the pharmacodynamic (PD) parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'title': 'DAY2', 'categories': [{'measurements': [{'value': '-1.50', 'spread': '5.839', 'groupId': 'OG000'}, {'value': '-2.04', 'spread': '6.238', 'groupId': 'OG001'}]}]}, {'title': 'DAY3', 'categories': [{'measurements': [{'value': '-1.71', 'spread': '9.012', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '7.665', 'groupId': 'OG001'}]}]}, {'title': 'DAY8', 'categories': [{'measurements': [{'value': '-18.89', 'spread': '6.814', 'groupId': 'OG000'}, {'value': '-20.39', 'spread': '8.526', 'groupId': 'OG001'}]}]}, {'title': 'DAY15', 'categories': [{'measurements': [{'value': '-19.57', 'spread': '12.554', 'groupId': 'OG000'}, {'value': '-21.85', 'spread': '11.371', 'groupId': 'OG001'}]}]}, {'title': 'DAY30', 'categories': [{'measurements': [{'value': '-10.46', 'spread': '14.303', 'groupId': 'OG000'}, {'value': '-11.11', 'spread': '7.976', 'groupId': 'OG001'}]}]}, {'title': 'DAY60', 'categories': [{'measurements': [{'value': '-8.26', 'spread': '16.712', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '10.038', 'groupId': 'OG001'}]}]}, {'title': 'DAY90', 'categories': [{'measurements': [{'value': '-5.10', 'spread': '14.122', 'groupId': 'OG000'}, {'value': '-3.06', 'spread': '7.317', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in total cholesterol on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and treated who had at least 1 of the PD parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'title': 'DAY2', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '3.636', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '8.504', 'groupId': 'OG001'}]}]}, {'title': 'DAY3', 'categories': [{'measurements': [{'value': '-3.81', 'spread': '2.908', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '9.771', 'groupId': 'OG001'}]}]}, {'title': 'DAY8', 'categories': [{'measurements': [{'value': '-3.97', 'spread': '13.335', 'groupId': 'OG000'}, {'value': '-9.16', 'spread': '16.834', 'groupId': 'OG001'}]}]}, {'title': 'DAY15', 'categories': [{'measurements': [{'value': '-3.33', 'spread': '20.205', 'groupId': 'OG000'}, {'value': '-10.08', 'spread': '16.485', 'groupId': 'OG001'}]}]}, {'title': 'DAY30', 'categories': [{'measurements': [{'value': '8.96', 'spread': '18.824', 'groupId': 'OG000'}, {'value': '3.70', 'spread': '15.475', 'groupId': 'OG001'}]}]}, {'title': 'DAY60', 'categories': [{'measurements': [{'value': '8.19', 'spread': '13.457', 'groupId': 'OG000'}, {'value': '5.18', 'spread': '15.265', 'groupId': 'OG001'}]}]}, {'title': 'DAY90', 'categories': [{'measurements': [{'value': '6.74', 'spread': '14.464', 'groupId': 'OG000'}, {'value': '5.92', 'spread': '12.033', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in HDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and treated who had at least 1 of the PD parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'title': 'DAY2', 'categories': [{'measurements': [{'value': '2.94', 'spread': '9.247', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '7.817', 'groupId': 'OG001'}]}]}, {'title': 'DAY3', 'categories': [{'measurements': [{'value': '1.91', 'spread': '12.944', 'groupId': 'OG000'}, {'value': '2.80', 'spread': '11.548', 'groupId': 'OG001'}]}]}, {'title': 'DAY8', 'categories': [{'measurements': [{'value': '-14.65', 'spread': '9.005', 'groupId': 'OG000'}, {'value': '-12.10', 'spread': '15.647', 'groupId': 'OG001'}]}]}, {'title': 'DAY15', 'categories': [{'measurements': [{'value': '-14.95', 'spread': '19.076', 'groupId': 'OG000'}, {'value': '-15.93', 'spread': '16.486', 'groupId': 'OG001'}]}]}, {'title': 'DAY30', 'categories': [{'measurements': [{'value': '-9.86', 'spread': '22.385', 'groupId': 'OG000'}, {'value': '-6.03', 'spread': '16.710', 'groupId': 'OG001'}]}]}, {'title': 'DAY60', 'categories': [{'measurements': [{'value': '-12.77', 'spread': '23.668', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '15.380', 'groupId': 'OG001'}]}]}, {'title': 'DAY90', 'categories': [{'measurements': [{'value': '-7.42', 'spread': '19.649', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '10.818', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in LDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and treated who had at least 1 of the PD parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'title': 'DAY2', 'categories': [{'measurements': [{'value': '-15.93', 'spread': '18.320', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '28.947', 'groupId': 'OG001'}]}]}, {'title': 'DAY3', 'categories': [{'measurements': [{'value': '5.68', 'spread': '35.419', 'groupId': 'OG000'}, {'value': '-4.79', 'spread': '45.277', 'groupId': 'OG001'}]}]}, {'title': 'DAY8', 'categories': [{'measurements': [{'value': '-65.66', 'spread': '19.581', 'groupId': 'OG000'}, {'value': '-72.26', 'spread': '21.036', 'groupId': 'OG001'}]}]}, {'title': 'DAY15', 'categories': [{'measurements': [{'value': '-62.44', 'spread': '27.207', 'groupId': 'OG000'}, {'value': '-64.24', 'spread': '31.482', 'groupId': 'OG001'}]}]}, {'title': 'DAY30', 'categories': [{'measurements': [{'value': '-27.64', 'spread': '40.099', 'groupId': 'OG000'}, {'value': '-53.51', 'spread': '27.018', 'groupId': 'OG001'}]}]}, {'title': 'DAY60', 'categories': [{'measurements': [{'value': '11.09', 'spread': '50.942', 'groupId': 'OG000'}, {'value': '8.28', 'spread': '77.143', 'groupId': 'OG001'}]}]}, {'title': 'DAY90', 'categories': [{'measurements': [{'value': '-22.63', 'spread': '58.405', 'groupId': 'OG000'}, {'value': '-51.39', 'spread': '37.174', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in VLDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and treated who had at least 1 of the PD parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglyceride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'title': 'DAY2', 'categories': [{'measurements': [{'value': '-9.72', 'spread': '15.235', 'groupId': 'OG000'}, {'value': '-5.86', 'spread': '12.887', 'groupId': 'OG001'}]}]}, {'title': 'DAY3', 'categories': [{'measurements': [{'value': '-10.03', 'spread': '16.856', 'groupId': 'OG000'}, {'value': '-7.24', 'spread': '26.804', 'groupId': 'OG001'}]}]}, {'title': 'DAY8', 'categories': [{'measurements': [{'value': '-32.61', 'spread': '16.422', 'groupId': 'OG000'}, {'value': '-52.47', 'spread': '18.150', 'groupId': 'OG001'}]}]}, {'title': 'DAY15', 'categories': [{'measurements': [{'value': '-41.91', 'spread': '19.992', 'groupId': 'OG000'}, {'value': '-48.19', 'spread': '16.491', 'groupId': 'OG001'}]}]}, {'title': 'DAY30', 'categories': [{'measurements': [{'value': '-28.54', 'spread': '20.289', 'groupId': 'OG000'}, {'value': '-44.14', 'spread': '19.466', 'groupId': 'OG001'}]}]}, {'title': 'DAY60', 'categories': [{'measurements': [{'value': '-19.55', 'spread': '29.981', 'groupId': 'OG000'}, {'value': '-30.60', 'spread': '23.585', 'groupId': 'OG001'}]}]}, {'title': 'DAY90', 'categories': [{'measurements': [{'value': '7.26', 'spread': '59.830', 'groupId': 'OG000'}, {'value': '-21.26', 'spread': '28.335', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in triglyceride on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and treated who had at least 1 of the PD parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'classes': [{'title': 'DAY2', 'categories': [{'measurements': [{'value': '-1.39', 'spread': '7.609', 'groupId': 'OG000'}, {'value': '-2.40', 'spread': '6.649', 'groupId': 'OG001'}]}]}, {'title': 'DAY3', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '12.865', 'groupId': 'OG000'}, {'value': '-0.89', 'spread': '9.120', 'groupId': 'OG001'}]}]}, {'title': 'DAY8', 'categories': [{'measurements': [{'value': '-22.58', 'spread': '8.362', 'groupId': 'OG000'}, {'value': '-23.41', 'spread': '8.368', 'groupId': 'OG001'}]}]}, {'title': 'DAY15', 'categories': [{'measurements': [{'value': '-23.18', 'spread': '15.173', 'groupId': 'OG000'}, {'value': '-25.37', 'spread': '11.202', 'groupId': 'OG001'}]}]}, {'title': 'DAY30', 'categories': [{'measurements': [{'value': '-15.33', 'spread': '16.925', 'groupId': 'OG000'}, {'value': '-15.58', 'spread': '10.089', 'groupId': 'OG001'}]}]}, {'title': 'DAY60', 'categories': [{'measurements': [{'value': '-11.58', 'spread': '22.194', 'groupId': 'OG000'}, {'value': '-3.89', 'spread': '9.669', 'groupId': 'OG001'}]}]}, {'title': 'DAY90', 'categories': [{'measurements': [{'value': '-8.32', 'spread': '16.806', 'groupId': 'OG000'}, {'value': '-6.35', 'spread': '7.602', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in non-HDL on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled and treated who had at least 1 of the PD parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein A-1 (ApoA-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'timeFrame': 'Day 1, Day 15, Day 60, and Day 90', 'description': 'Percentage changes from baseline in ApoA-I on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study endpoint of percent changes from baseline in apolipoprotein A-1 (ApoA-I),apolipoprotein B (ApoB) total (including ApoB-48, ApoB-100), and apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90, were terminated due to changes of development plan. No data were collected for these terminated endpoints.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B (ApoB) Total (Including ApoB-48, ApoB-100)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'timeFrame': 'Day 1, Day 15, Day 60, and Day 90', 'description': 'Percentage changes from baseline in ApoB total (including ApoB-48, ApoB-100) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study endpoint of percent changes from baseline in apolipoprotein A-1 (ApoA-I),apolipoprotein B (ApoB) total (including ApoB-48, ApoB-100), and apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90, were terminated due to changes of development plan. No data were collected for these terminated endpoints.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein C-III (ApoC-III)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'OG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'timeFrame': 'Day 1, Day 15, Day 60, and Day 90', 'description': 'Percentage changes from baseline in apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study endpoint of percent changes from baseline in apolipoprotein A-1 (ApoA-I),apolipoprotein B (ApoB) total (including ApoB-48, ApoB-100), and apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90, were terminated due to changes of development plan. No data were collected for these terminated endpoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'FG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vupanorsen 80 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 80 mg group and received a single 80 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'BG001', 'title': 'Vupanorsen 160 mg', 'description': 'Participants were selected and categorized into the Vupanorsen 160 mg group and received a single 160 mg subcutaneous dose of vupanorsen on Day 1, followed by an on-site post-treatment evaluation on Days 8, 15, 30, 60 and 90.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.44', 'spread': '7.13', 'groupId': 'BG000'}, {'value': '36.22', 'spread': '8.45', 'groupId': 'BG001'}, {'value': '33.83', 'spread': '7.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants enrolled and who took at least 1 dose of study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-28', 'size': 1946099, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-02T11:20', 'hasProtocol': True}, {'date': '2020-10-16', 'size': 1386966, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-02T11:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-20', 'studyFirstSubmitDate': '2021-06-01', 'resultsFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2021-06-01', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-20', 'studyFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC24h) for Vupanorsen', 'timeFrame': '0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on day 1', 'description': 'AUC24h is the area under the concentration-time profile from time 0 to 24 hour post-dose'}, {'measure': 'AUC From Time 0 to 48 Hours Post-dose (AUC48h) for Vupanorsen', 'timeFrame': '0 hour (predose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post dose', 'description': 'AUC48h is the area under the plasma concentration-time profile from time zero to the quantifiable concentration 48 hours post-dose'}, {'measure': 'AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for Vupanorsen', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)'}, {'measure': 'Maximum Observed Concentration (Cmax)', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'Maximum plasma concentration observed from data'}, {'measure': 'AUC From Time 0 Extrapolated to Infinite Time (AUCinf) for Vupanorsen', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'AUCinf is area under the plasma concentration-time profile from time zero extrapolated to infinite time'}, {'measure': 'Time for Cmax (Tmax) for Vupanorsen', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'Time for Cmax (Tmax) for vupanorsen'}, {'measure': 'Terminal Elimination Half Life (t½) for Vupanorsen', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'terminal elimination half life (t½) for vupanorsen'}, {'measure': 'Apparent Clearance (CL/F) for Vupanorsen', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'Apparent clearance for vupanorsen'}, {'measure': 'Apparent Volume of Distribution (Vz/F) for Vupanorsen', 'timeFrame': '0 hour (predose), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post dose, and on days 8, 15, 30, 60 and 90', 'description': 'Apparent volume of distribution for vupanorsen'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline through day 90', 'description': 'Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Causality to study treatment was determined by the investigator.'}, {'measure': 'Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)', 'timeFrame': 'Baseline through day 90', 'description': 'Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria.'}, {'measure': 'Number of Participants With Clinically Significant Vital Sign Values', 'timeFrame': 'Baseline through day 90', 'description': 'Vital sign data included blood pressure and pulse rate. Clinical significance was assessed by the investigator.'}, {'measure': 'Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values', 'timeFrame': 'Baseline through day 90', 'description': 'Clinical significance of ECG data was assessed by the investigator.'}, {'measure': 'Percent Changes From Baseline in Angiopoietin-Like 3 (ANGPTL3)', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percent changes from baseline in ANGPTL3 on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90'}, {'measure': 'Percent Change From Baseline in Total Cholesterol', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in total cholesterol on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90'}, {'measure': 'Percent Changs From Baseline in High-density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in HDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90'}, {'measure': 'Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in LDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90'}, {'measure': 'Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in VLDL-C on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90'}, {'measure': 'Percent Change From Baseline in Triglyceride', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in triglyceride on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90'}, {'measure': 'Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'timeFrame': 'Day 1, Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90', 'description': 'Percentage changes from baseline in non-HDL on Day 2, Day 3, Day 8, Day 15, Day 30, Day 60 and Day 90'}, {'measure': 'Percent Change From Baseline in Apolipoprotein A-1 (ApoA-I)', 'timeFrame': 'Day 1, Day 15, Day 60, and Day 90', 'description': 'Percentage changes from baseline in ApoA-I on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B (ApoB) Total (Including ApoB-48, ApoB-100)', 'timeFrame': 'Day 1, Day 15, Day 60, and Day 90', 'description': 'Percentage changes from baseline in ApoB total (including ApoB-48, ApoB-100) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein C-III (ApoC-III)', 'timeFrame': 'Day 1, Day 15, Day 60, and Day 90', 'description': 'Percentage changes from baseline in apolipoprotein C-III (ApoC-III) on Day 15, Day 60, and Day 90. This endpoint was terminated due to changes of development plan.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '38949758', 'type': 'DERIVED', 'citation': 'Wu X, Yu J, Ge B, Wang J, Han X, Zhang C, Mao X, Kalluru H, Bramson C, Terra SG, Liu J. A Randomized, Open-Label, Phase I, Single-Dose Study of Antisense Oligonucleotide, Vupanorsen, in Chinese Adults with Elevated Triglycerides. Drugs R D. 2024 Jun;24(2):253-262. doi: 10.1007/s40268-024-00467-5. Epub 2024 Jul 1.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4491004', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, randomized, parallel-cohort, open-label study to characterize the pharmacokinetics, pharmacodynamics, safety and tolerability of vupanorsen following 80 mg and 160 mg single subcutaneous dose in healthy Chinese adults with elevated fasting triglyceride.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female Chinese participants must be 18 to 65 years of age, inclusive, at the time of signing the ICD.\n\n * Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.\n * Chinese participant is defined as individuals currently residing in mainland China who were born in China and have both parents of Chinese descent.\n2. Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests (except for TG levels), and 12-lead ECG monitoring.\n3. Fasting TG ≥ 90 mg/dL at Screening (up to 1 repeat allowed for TG and the second TG value will be used for the eligibility).\n4. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n5. BMI of 17.5 to 35.0 kg/m2; and a total body weight \\>50 kg (110 lb).\n6. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.\n\nExclusion Criteria:\n\n1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n2. History of human immunodeficiency virus (HIV) infection, syphilis, hepatitis B, or hepatitis C; positive testing for HIV, syphilis, HBsAg, or HCVAb. Prior Hepatitis B vaccination is allowed.\n3. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n4. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.\n5. Previous administration with an investigational drug within 4 months or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).\n6. A positive urine drug test.\n7. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.\n8. Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval \\>450 msec, complete LBBB, signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is \\>450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.\n9. Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:\n\n * AST or ALT level ≥1.25 × ULN;\n * Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is≤ ULN.\n10. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).\n11. Blood donation (excluding plasma donations) of approximately 400 mL or more within 60 days prior to dosing.\n12. History of sensitivity to heparin or heparin-induced thrombocytopenia.\n13. History of substance abuse within 12 months of the screening visit.\n14. Pregnant females; breastfeeding females.\n15. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.\n16. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members."}, 'identificationModule': {'nctId': 'NCT04916795', 'briefTitle': 'A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Tolerability Of Single Dose Vupanorsen In Healthy Chinese Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, RANDOMIZED, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF VUPANORSEN ADMINISTERED SUBCUTANEOUSLY TO HEALTHY CHINESE ADULTS', 'orgStudyIdInfo': {'id': 'C4491004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vupanorsen 80 milligram (mg)', 'description': 'Participants will receive one, 0.8 milliliter (mL) subcutaneous injection with vupanorsen 100 mg/mL solution', 'interventionNames': ['Drug: Vupanorsen']}, {'type': 'EXPERIMENTAL', 'label': 'Vupanorsen 160 milligram (mg)', 'description': 'Participants will receive two, 0.8 mL subcutaneous injections with vupanorsen 100 mg/mL solution', 'interventionNames': ['Drug: Vupanorsen']}], 'interventions': [{'name': 'Vupanorsen', 'type': 'DRUG', 'description': '80 mg subcutaneous injection', 'armGroupLabels': ['Vupanorsen 80 milligram (mg)']}, {'name': 'Vupanorsen', 'type': 'DRUG', 'description': '80 mg subcutaneous injection', 'armGroupLabels': ['Vupanorsen 160 milligram (mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201107', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital,Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}