Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-01-06 @ 6:27 PM
Study NCT ID:
NCT03170193
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2017-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AMG 529 First in Human Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AMG 529 21 mg SC', 'description': 'Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'AMG 529 70 mg SC', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.'}, {'id': 'OG001', 'title': 'AMG 529 21 mg SC', 'description': 'Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.'}, {'id': 'OG002', 'title': 'AMG 529 70 mg SC', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG003', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG004', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG005', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG006', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.'}], 'classes': [{'title': 'All adverse events', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Adverse events Grade ≥ 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Adverse events Grade ≥ 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Adverse events Grade ≥ 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Serious adverse events', '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'}]}]}, {'title': 'AEs leading to discontinuation of study drug', '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'}]}]}, {'title': 'Treatment-related adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Fatal adverse events', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.', 'description': 'Determination of the severity of adverse events was according to the following: grade 1 = mild (eg, asymptomatic or mild symptoms); grade 2 = moderate (eg, minimal intervention indicated or interferes with activity); grade 3 = severe (eg, medically significant but not immediately life-threatening, prevents daily activity, or requires treatment); grade 4 = life-threatening (ie, refers to an event in which the participant was, in the view of the investigator, at risk of death at the time of the event); and grade 5 = fatal.\n\nA serious adverse event was defined as an adverse event that met at least 1 of the following criteria:\n\n* fatal\n* life threatening\n* required in patient hospitalization or prolongation of existing hospitalization\n* resulted in persistent or significant disability/incapacity\n* congenital anomaly/birth defect\n* other medically important serious event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of AMG 529 or placebo.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax) of AMG 529', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 529 21 mg SC', 'description': 'Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'AMG 529 70 mg SC', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG002', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG003', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG004', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG005', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.90', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '2010', 'spread': '3120', 'groupId': 'OG002'}, {'value': '9370', 'spread': '10800', 'groupId': 'OG003'}, {'value': '35600', 'spread': '32700', 'groupId': 'OG004'}, {'value': '3460', 'spread': '4430', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received AMG 529 for whom at least 1 PK parameter or endpoint was reliably estimated. Four participants were excluded from PK analyses as their profiles had \\< 2 samples that were above the lower limit of quantification.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Observed Concentration (Tmax) of AMG 529', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 529 21 mg SC', 'description': 'Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'AMG 529 70 mg SC', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG002', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG003', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG004', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG005', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '24'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '5.8'}, {'value': '72', 'groupId': 'OG002', 'lowerLimit': '24', 'upperLimit': '72'}, {'value': '72', 'groupId': 'OG003', 'lowerLimit': '24', 'upperLimit': '72'}, {'value': '96', 'groupId': 'OG004', 'lowerLimit': '36', 'upperLimit': '170'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received AMG 529 for whom at least 1 PK parameter or endpoint was reliably estimated. Four participants were excluded from PK analyses as their profiles had \\< 2 samples that were above the lower limit of quantification.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 529 21 mg SC', 'description': 'Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'AMG 529 70 mg SC', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG002', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG003', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG004', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG005', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.99', 'spread': '2.90', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '47.4', 'groupId': 'OG001'}, {'value': '5370', 'spread': '8520', 'groupId': 'OG002'}, {'value': '41800', 'spread': '51000', 'groupId': 'OG003'}, {'value': '289000', 'spread': '330000', 'groupId': 'OG004'}, {'value': '766', 'spread': '1240', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.', 'unitOfMeasure': 'days*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received AMG 529 for whom at least 1 PK parameter or endpoint was reliably estimated. Four participants were excluded from PK analyses as their profiles had \\< 2 samples that were above the lower limit of quantification.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.'}, {'id': 'OG001', 'title': 'AMG 529 21 mg SC', 'description': 'Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.'}, {'id': 'OG002', 'title': 'AMG 529 70 mg SC', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG003', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG004', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG005', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG006', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': 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'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '5.3', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '4.0', 'groupId': 'OG003'}, {'value': '11.8', 'spread': '5.9', 'groupId': 'OG004'}, {'value': '14.6', 'spread': '6.5', 'groupId': 'OG005'}, {'value': '2.0', 'spread': '7.8', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and days 3, 8, and 30', 'unitOfMeasure': 'units/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 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{'id': 'OG003', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG004', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG005', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG006', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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'}]}], 'categories': 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'groupId': 'OG002'}, {'value': '0.0800', 'spread': '0.2224', 'groupId': 'OG003'}, {'value': '0.1617', 'spread': '0.2375', 'groupId': 'OG004'}, {'value': '0.2350', 'spread': '0.1299', 'groupId': 'OG005'}, {'value': '0.3400', 'spread': '0.3428', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.0867', 'spread': '0.4151', 'groupId': 'OG000'}, {'value': '-0.3317', 'spread': '0.1997', 'groupId': 'OG001'}, {'value': '-0.3533', 'spread': '0.3426', 'groupId': 'OG002'}, {'value': '-0.2520', 'spread': '0.6208', 'groupId': 'OG003'}, {'value': '-0.3267', 'spread': '0.3140', 'groupId': 'OG004'}, {'value': '-0.1667', 'spread': '0.2614', 'groupId': 'OG005'}, {'value': '0.3350', 'spread': '0.5461', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.4625', 'spread': '0.4110', 'groupId': 'OG000'}, {'value': '-1.0620', 'spread': '0.5976', 'groupId': 'OG001'}, {'value': '-0.6933', 'spread': '0.4763', 'groupId': 'OG002'}, {'value': '-0.6700', 'spread': '0.5770', 'groupId': 'OG003'}, {'value': '-0.8500', 'spread': '0.6339', 'groupId': 'OG004'}, {'value': '-0.7600', 'spread': '0.5306', 'groupId': 'OG005'}, {'value': '-0.0340', 'spread': '0.8344', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.0300', 'spread': '0.5567', 'groupId': 'OG000'}, {'value': '-0.7480', 'spread': '0.8825', 'groupId': 'OG001'}, {'value': '-0.2550', 'spread': '0.5021', 'groupId': 'OG002'}, {'value': '-0.1640', 'spread': '0.3092', 'groupId': 'OG003'}, {'value': '-0.2183', 'spread': '0.4100', 'groupId': 'OG004'}, {'value': '-0.2040', 'spread': '0.5358', 'groupId': 'OG005'}, {'value': '-0.3200', 'spread': '0.9193', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.0936', 'spread': '0.7880', 'groupId': 'OG000'}, {'value': '-0.6780', 'spread': '0.3467', 'groupId': 'OG001'}, {'value': '-0.1933', 'spread': '0.4376', 'groupId': 'OG002'}, {'value': '0.1300', 'spread': '0.0919', 'groupId': 'OG003'}, {'value': '0.2583', 'spread': '0.4088', 'groupId': 'OG004'}, {'value': '0.1380', 'spread': '0.4964', 'groupId': 'OG005'}, {'value': '-0.1140', 'spread': '0.9209', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.1840', 'spread': '0.7451', 'groupId': 'OG000'}, {'value': '0.5120', 'spread': '0.8889', 'groupId': 'OG003'}, {'value': '0.2383', 'spread': '0.4896', 'groupId': 'OG004'}, {'value': '-0.0033', 'spread': '0.9705', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received study drug with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.'}, {'id': 'OG001', 'title': 'AMG 529 21 mg SC', 'description': 'Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.'}, {'id': 'OG002', 'title': 'AMG 529 70 mg SC', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG003', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG004', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG005', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG006', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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'}]}], 'categories': [{'measurements': [{'value': '2.8317', 'spread': '0.8071', 'groupId': 'OG000'}, {'value': '3.2683', 'spread': '1.0026', 'groupId': 'OG001'}, {'value': '2.8400', 'spread': '0.7687', 'groupId': 'OG002'}, {'value': '3.4017', 'spread': '1.2875', 'groupId': 'OG003'}, {'value': '2.4633', 'spread': '0.5727', 'groupId': 'OG004'}, {'value': '3.2267', 'spread': '0.7112', 'groupId': 'OG005'}, {'value': '3.1583', 'spread': '1.1382', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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'}]}], 'categories': [{'measurements': [{'value': '0.1608', 'spread': '0.2423', 'groupId': 'OG000'}, {'value': '0.1383', 'spread': '0.3271', 'groupId': 'OG001'}, {'value': '0.2150', 'spread': '0.1571', 'groupId': 'OG002'}, {'value': '-0.0867', 'spread': '0.3280', 'groupId': 'OG003'}, {'value': '0.2650', 'spread': '0.1401', 'groupId': 'OG004'}, {'value': '0.3350', 'spread': '0.2482', 'groupId': 'OG005'}, {'value': '0.3350', 'spread': '0.2874', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 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'0.4298', 'groupId': 'OG000'}, {'value': '-0.7600', 'spread': '0.4464', 'groupId': 'OG001'}, {'value': '-0.3900', 'spread': '0.2912', 'groupId': 'OG002'}, {'value': '-0.7920', 'spread': '0.4873', 'groupId': 'OG003'}, {'value': '-0.7333', 'spread': '0.5000', 'groupId': 'OG004'}, {'value': '-0.5850', 'spread': '0.2204', 'groupId': 'OG005'}, {'value': '-0.0520', 'spread': '0.5955', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.0117', 'spread': '0.4577', 'groupId': 'OG000'}, {'value': '-0.5240', 'spread': '0.8043', 'groupId': 'OG001'}, {'value': '-0.0600', 'spread': '0.3205', 'groupId': 'OG002'}, {'value': '-0.2860', 'spread': '0.4116', 'groupId': 'OG003'}, {'value': '-0.3517', 'spread': '0.3969', 'groupId': 'OG004'}, {'value': '-0.3960', 'spread': '0.1521', 'groupId': 'OG005'}, {'value': '-0.2780', 'spread': '0.7706', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.1018', 'spread': '0.6698', 'groupId': 'OG000'}, {'value': '-0.4260', 'spread': '0.4258', 'groupId': 'OG001'}, {'value': '-0.0767', 'spread': '0.4002', 'groupId': 'OG002'}, {'value': '-0.4020', 'spread': '0.4773', 'groupId': 'OG003'}, {'value': '0.2667', 'spread': '0.3768', 'groupId': 'OG004'}, {'value': '-0.0740', 'spread': '0.4999', 'groupId': 'OG005'}, {'value': '-0.2680', 'spread': '0.9091', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.0500', 'spread': '0.7559', 'groupId': 'OG000'}, {'value': '0.0520', 'spread': '0.6514', 'groupId': 'OG003'}, {'value': '0.1283', 'spread': '0.3075', 'groupId': 'OG004'}, {'value': '-0.1617', 'spread': '0.8583', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized 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injection.'}, {'id': 'OG003', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG004', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG005', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG006', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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'}]}], 'categories': [{'measurements': [{'value': '1.1775', 'spread': '0.2932', 'groupId': 'OG000'}, {'value': '1.3783', 'spread': '0.2928', 'groupId': 'OG001'}, {'value': '1.3950', 'spread': '0.2626', 'groupId': 'OG002'}, {'value': '1.4133', 'spread': '0.4968', 'groupId': 'OG003'}, {'value': '1.2633', 'spread': '0.2202', 'groupId': 'OG004'}, {'value': '1.0700', 'spread': '0.4527', 'groupId': 'OG005'}, {'value': '1.4417', 'spread': '0.5517', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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'}]}], 'categories': [{'measurements': [{'value': '-0.0592', 'spread': '0.1094', 'groupId': 'OG000'}, {'value': '-0.0100', 'spread': '0.1092', 'groupId': 'OG001'}, {'value': '-0.1267', 'spread': '0.0935', 'groupId': 'OG002'}, {'value': '0.0417', 'spread': '0.1032', 'groupId': 'OG003'}, {'value': '-0.0600', 'spread': '0.1373', 'groupId': 'OG004'}, {'value': '0.0783', 'spread': '0.0981', 'groupId': 'OG005'}, {'value': '-0.0383', 'spread': '0.1118', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.0975', 'spread': '0.1096', 'groupId': 'OG000'}, {'value': '-0.1617', 'spread': '0.1254', 'groupId': 'OG001'}, {'value': '-0.2083', 'spread': '0.1430', 'groupId': 'OG002'}, {'value': '-0.0980', 'spread': '0.1417', 'groupId': 'OG003'}, {'value': '-0.1100', 'spread': '0.2028', 'groupId': 'OG004'}, {'value': '0.0350', 'spread': '0.1816', 'groupId': 'OG005'}, {'value': '-0.0767', 'spread': '0.1402', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.0133', 'spread': '0.1224', 'groupId': 'OG000'}, {'value': '-0.2080', 'spread': '0.1854', 'groupId': 'OG001'}, {'value': '-0.1600', 'spread': '0.1689', 'groupId': 'OG002'}, {'value': '-0.0960', 'spread': '0.1318', 'groupId': 'OG003'}, {'value': '-0.0800', 'spread': '0.0812', 'groupId': 'OG004'}, {'value': '0.0475', 'spread': '0.0768', 'groupId': 'OG005'}, {'value': '-0.0060', 'spread': '0.1809', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.0208', 'spread': '0.1468', 'groupId': 'OG000'}, {'value': '-0.0580', 'spread': '0.1644', 'groupId': 'OG001'}, {'value': '-0.0417', 'spread': '0.1815', 'groupId': 'OG002'}, {'value': '0.0220', 'spread': '0.1026', 'groupId': 'OG003'}, {'value': '0.0583', 'spread': '0.1533', 'groupId': 'OG004'}, {'value': '0.2860', 'spread': '0.1704', 'groupId': 'OG005'}, {'value': '0.0320', 'spread': '0.1583', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.0473', 'spread': '0.1769', 'groupId': 'OG000'}, {'value': '-0.0760', 'spread': '0.0853', 'groupId': 'OG001'}, {'value': '-0.0400', 'spread': '0.3107', 'groupId': 'OG002'}, {'value': '0.1380', 'spread': '0.1644', 'groupId': 'OG003'}, {'value': '0.0667', 'spread': '0.2060', 'groupId': 'OG004'}, {'value': '0.2480', 'spread': '0.0944', 'groupId': 'OG005'}, {'value': '0.1340', 'spread': '0.1396', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.0540', 'spread': '0.1549', 'groupId': 'OG000'}, {'value': '0.1160', 'spread': '0.1595', 'groupId': 'OG003'}, {'value': '0.1483', 'spread': '0.1113', 'groupId': 'OG004'}, {'value': '0.2633', 'spread': '0.2470', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received study drug with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Triglycerides Concentration Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.'}, {'id': 'OG001', 'title': 'AMG 529 21 mg SC', 'description': 'Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.'}, {'id': 'OG002', 'title': 'AMG 529 70 mg SC', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG003', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG004', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG005', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'OG006', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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'}]}], 'categories': [{'measurements': [{'value': '1.2292', 'spread': '0.5080', 'groupId': 'OG000'}, {'value': '1.1100', 'spread': '0.5588', 'groupId': 'OG001'}, {'value': '1.0050', 'spread': '0.5478', 'groupId': 'OG002'}, {'value': '1.3750', 'spread': '0.9770', 'groupId': 'OG003'}, {'value': '1.0533', 'spread': '0.3525', 'groupId': 'OG004'}, {'value': '1.5067', 'spread': '1.0848', 'groupId': 'OG005'}, {'value': '0.8317', 'spread': '0.3036', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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'}]}], 'categories': [{'measurements': [{'value': '-0.0942', 'spread': '0.2880', 'groupId': 'OG000'}, {'value': '-0.1283', 'spread': '0.1379', 'groupId': 'OG001'}, {'value': '-0.0633', 'spread': '0.2366', 'groupId': 'OG002'}, {'value': '-0.0183', 'spread': '0.3725', 'groupId': 'OG003'}, {'value': '-0.1833', 'spread': '0.0993', 'groupId': 'OG004'}, {'value': '-0.5600', 'spread': '0.6615', 'groupId': 'OG005'}, {'value': '0.0750', 'spread': '0.1244', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.0525', 'spread': '0.3015', 'groupId': 'OG000'}, {'value': '-0.0450', 'spread': '0.1148', 'groupId': 'OG001'}, {'value': '-0.0583', 'spread': '0.1932', 'groupId': 'OG002'}, {'value': '0.4580', 'spread': '1.2469', 'groupId': 'OG003'}, {'value': '-0.2900', 'spread': '0.2521', 'groupId': 'OG004'}, {'value': '-0.5783', 'spread': '0.5958', 'groupId': 'OG005'}, {'value': '0.3133', 'spread': '0.3102', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-0.0975', 'spread': '0.3470', 'groupId': 'OG000'}, {'value': '0.2040', 'spread': '0.7577', 'groupId': 'OG001'}, {'value': '0.1400', 'spread': '0.4963', 'groupId': 'OG002'}, {'value': '0.1840', 'spread': '0.4797', 'groupId': 'OG003'}, {'value': '-0.1167', 'spread': '0.4131', 'groupId': 'OG004'}, {'value': '-0.5925', 'spread': '1.0357', 'groupId': 'OG005'}, {'value': '0.3320', 'spread': '0.5496', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.0475', 'spread': '0.5965', 'groupId': 'OG000'}, {'value': '0.0920', 'spread': '0.2212', 'groupId': 'OG001'}, {'value': '0.5800', 'spread': '0.6549', 'groupId': 'OG002'}, {'value': '0.1780', 'spread': '0.4043', 'groupId': 'OG003'}, {'value': '0.2183', 'spread': '0.2193', 'groupId': 'OG004'}, {'value': '-0.4360', 'spread': '0.9239', 'groupId': 'OG005'}, {'value': '0.3340', 'spread': '0.4185', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.0991', 'spread': '0.4538', 'groupId': 'OG000'}, {'value': '0.2320', 'spread': '0.3214', 'groupId': 'OG001'}, {'value': '0.5533', 'spread': '0.7672', 'groupId': 'OG002'}, {'value': '0.2600', 'spread': '0.5742', 'groupId': 'OG003'}, {'value': '0.0533', 'spread': '0.4320', 'groupId': 'OG004'}, {'value': '-0.0360', 'spread': '0.5330', 'groupId': 'OG005'}, {'value': '0.2220', 'spread': '0.1580', 'groupId': 'OG006'}]}]}, {'title': 'Change from baseline to day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.4580', 'spread': '0.5334', 'groupId': 'OG000'}, {'value': '0.4900', 'spread': '0.7883', 'groupId': 'OG003'}, {'value': '0.0533', 'spread': '0.3663', 'groupId': 'OG004'}, {'value': '-0.3283', 'spread': '0.5669', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received study drug with available data at each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.'}, {'id': 'FG001', 'title': 'AMG 529 21 mg SC', 'description': 'Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.'}, {'id': 'FG002', 'title': 'AMG 529 70 mg SC', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'FG003', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'FG004', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'FG005', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'FG006', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at a single center in the United States. Participants were enrolled from 15 May 2017 to 18 September 2017.', 'preAssignmentDetails': 'Participants were enrolled into one of six dose cohorts. Within each cohort participants were randomized in a ratio of 3:1 to receive AMG 529 or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', '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': '48', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received a single dose of matching placebo by either subcutaneous or intravenous injection.'}, {'id': 'BG001', 'title': 'AMG 529 21 mg SC', 'description': 'Participants received a single dose of 21 mg AMG 529 on study day 1 by subcutaneous (SC) injection.'}, {'id': 'BG002', 'title': 'AMG 529 70 mg SC', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'BG003', 'title': 'AMG 529 210 mg SC', 'description': 'Participants received a single dose of 210 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'BG004', 'title': 'AMG 529 420 mg SC', 'description': 'Participants received a single dose of 420 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'BG005', 'title': 'AMG 529 700 mg SC', 'description': 'Participants received a single dose of 700 mg AMG 529 on study day 1 by subcutaneous injection.'}, {'id': 'BG006', 'title': 'AMG 529 70 mg IV', 'description': 'Participants received a single dose of 70 mg AMG 529 on study day 1 by intravenous (IV) injection.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '33.5', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '32.3', 'spread': '11.6', 'groupId': 'BG002'}, {'value': '45.2', 'spread': '11.6', 'groupId': 'BG003'}, {'value': '35.0', 'spread': '11.0', 'groupId': 'BG004'}, {'value': '36.5', 'spread': '9.6', 'groupId': 'BG005'}, {'value': '34.7', 'spread': '12.7', 'groupId': 'BG006'}, {'value': '36.1', 'spread': '11.1', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '46', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Black', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-01', 'size': 1986527, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-12T11:57', 'hasProtocol': True}, {'date': '2017-07-20', 'size': 509782, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-12T11:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Within each dose cohort participants were randomized in a 3:1 ratio to receive either AMG 529 or placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2017-05-25', 'resultsFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2017-05-25', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-12', 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.', 'description': 'Determination of the severity of adverse events was according to the following: grade 1 = mild (eg, asymptomatic or mild symptoms); grade 2 = moderate (eg, minimal intervention indicated or interferes with activity); grade 3 = severe (eg, medically significant but not immediately life-threatening, prevents daily activity, or requires treatment); grade 4 = life-threatening (ie, refers to an event in which the participant was, in the view of the investigator, at risk of death at the time of the event); and grade 5 = fatal.\n\nA serious adverse event was defined as an adverse event that met at least 1 of the following criteria:\n\n* fatal\n* life threatening\n* required in patient hospitalization or prolongation of existing hospitalization\n* resulted in persistent or significant disability/incapacity\n* congenital anomaly/birth defect\n* other medically important serious event.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of AMG 529', 'timeFrame': 'Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.'}, {'measure': 'Time to Maximum Observed Concentration (Tmax) of AMG 529', 'timeFrame': 'Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.'}, {'measure': 'Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529', 'timeFrame': 'Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.'}, {'measure': 'Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time', 'timeFrame': 'Baseline and days 3, 8, and 30'}, {'measure': 'Change From Baseline in Total Cholesterol Concentration Over Time', 'timeFrame': 'Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.'}, {'measure': 'Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time', 'timeFrame': 'Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.'}, {'measure': 'Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time', 'timeFrame': 'Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.'}, {'measure': 'Change From Baseline in Triglycerides Concentration Over Time', 'timeFrame': 'Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'A study to assess the safety and tolerability of AMG 529 following single, ascending doses administered subcutaneously (SC) or intravenously (IV) in healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically relevant medical disorders\n2. Body mass index (BMI) between 18 and 32 kg/m², inclusive, at screening\n3. Women must be of non-reproductive potential as defined in protocol\n4. Other inclusion criteria may apply\n\nExclusion Criteria:\n\n1. Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives (whichever is longer), since ending treatment on another investigational device or drug study(s) prior to receiving the first dose of investigational product\n2. Women who are lactating/breastfeeding or who plan to breastfeed while on study through 90 days after receiving the dose of investigational product\n3. Men with partners who are pregnant or planning to become pregnant while the subject is on study through 90 days after receiving the dose of investigational product\n4. Positive pregnancy test at screening or day -1\n5. Other exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03170193', 'briefTitle': 'AMG 529 First in Human Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 529 in Healthy Subjects', 'orgStudyIdInfo': {'id': '20160338'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMG 529', 'description': 'Participants received a single dose of AMG 529 at ascending dose levels by either subcutaneous or intravenous injection.', 'interventionNames': ['Drug: AMG 529']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received a single dose of placebo matching to AMG 529 by either subcutaneous or intravenous injection.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AMG 529', 'type': 'DRUG', 'description': 'Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection', 'armGroupLabels': ['AMG 529']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single doses of matching placebo by SC or IV injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}