Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT04076293
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2019-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jiyeon.kang@hanmi.co.kr', 'phone': '8224100377', 'title': 'Jiyeon Kang', 'organization': 'Hanmi Pharmaceutical Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Screening, Day1 to 7, Day 10, Day 17, and Day 30', 'description': 'An AE was defined as any untoward medical occurrence in subjects and which did not necessarily have a causal relationship with the IMP. An AE could therefore have been any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease, whether or not it was related to the IP.', 'eventGroups': [{'id': 'EG000', 'title': 'HM15912 0.05mg/kg', 'description': 'HM15912 0.05mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'HM15912 0.1mg/kg', 'description': 'HM15912 0.1mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'HM15912 0.5mg/kg', 'description': 'HM15912 0.5mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'HM15912 1.0mg/kg', 'description': 'HM15912 1.0mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'HM15912 1.5mg/kg', 'description': 'HM15912 1.5mg/kg: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo', 'description': 'Placebo: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'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': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, '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': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, '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': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events of HM15912', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'HM15912 0.05mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG001', 'title': 'HM15912 0.1mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG002', 'title': 'HM15912 0.5mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG003', 'title': 'HM15912 1.0mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG004', 'title': 'HM15912 1.5mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}], 'classes': [{'categories': [{'title': 'Mild TEAE', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'Moderate TEAE', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'No AE', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'after single subcutaneous (SC) doses for 44 days', 'description': 'Number of participants with any treatment-emergent adverse events related to study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each analysis population was included in the analyses, based on the actually administered IMP and dosage.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Significant Findings Observed for Hematology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'HM15912 0.05mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG001', 'title': 'HM15912 0.1mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG002', 'title': 'HM15912 0.5mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG003', 'title': 'HM15912 1.0mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG004', 'title': 'HM15912 1.5mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo: Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). Total of 10 subjects for placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'after single subcutaneous (SC) doses for 44 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Concentration Max Profile of HM15912', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'HM15912 0.05mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG001', 'title': 'HM15912 0.1mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG002', 'title': 'HM15912 0.5mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG003', 'title': 'HM15912 1.0mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG004', 'title': 'HM15912 1.5mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo: Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). Total of 10 subjects for placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '249.45', 'spread': '51.77', 'groupId': 'OG000'}, {'value': '622.46', 'spread': '14.06', 'groupId': 'OG001'}, {'value': '3550.79', 'spread': '36.44', 'groupId': 'OG002'}, {'value': '8347.70', 'spread': '10.30', 'groupId': 'OG003'}, {'value': '9393.06', 'spread': '13.24', 'groupId': 'OG004'}, {'value': '0', 'spread': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30', 'description': 'To assess the Concentration Max profile of HM15912 after single SC doses.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HM15912 0.05mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'FG001', 'title': 'HM15912 0.1mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'FG002', 'title': 'HM15912 0.5mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'FG003', 'title': 'HM15912 1.0mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'FG004', 'title': 'HM15912 1.5mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'FG005', 'title': 'Placebo', 'description': 'Placebo: Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo). Total of 10 subjects for placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Date of first enrollment was October 8th, 2019.', 'preAssignmentDetails': 'The planned maximum dose of HM15912 was 1.5 mg/kg; however, higher doses were allowed to be administered if safety was confirmed in previous cohorts. If dose was escalated to more than 1.5 mg/kg, Ministry of Food and Drug Safety (MFDS) approval was to be obtained.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'HM15912 0.05mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'BG001', 'title': 'HM15912 0.1mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'BG002', 'title': 'HM15912 0.5mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'BG003', 'title': 'HM15912 1.0 mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'BG004', 'title': 'HM15912 1.5mg/kg', 'description': 'HM15912: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'BG005', 'title': 'Placebo', 'description': 'Placebo: The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '5.18', 'groupId': 'BG000'}, {'value': '28.3', 'spread': '8.87', 'groupId': 'BG001'}, {'value': '26.0', 'spread': '5.83', 'groupId': 'BG002'}, {'value': '25.0', 'spread': '3.52', 'groupId': 'BG003'}, {'value': '31.7', 'spread': '7.39', 'groupId': 'BG004'}, {'value': '27.2', 'spread': '2.39', 'groupId': 'BG005'}, {'value': '28.4', 'spread': '6.54', 'groupId': 'BG006'}]}]}], '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': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Korean', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-06', 'size': 889473, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-21T01:33', 'hasProtocol': True}, {'date': '2020-08-18', 'size': 1202924, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-21T01:34', '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2019-08-26', 'resultsFirstSubmitDate': '2022-03-18', 'studyFirstSubmitQcDate': '2019-08-30', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-23', 'studyFirstPostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events of HM15912', 'timeFrame': 'after single subcutaneous (SC) doses for 44 days', 'description': 'Number of participants with any treatment-emergent adverse events related to study medication.'}, {'measure': 'Number of Participants With Significant Findings Observed for Hematology', 'timeFrame': 'after single subcutaneous (SC) doses for 44 days'}], 'secondaryOutcomes': [{'measure': 'Concentration Max Profile of HM15912', 'timeFrame': 'after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30', 'description': 'To assess the Concentration Max profile of HM15912 after single SC doses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacology']}, 'descriptionModule': {'briefSummary': 'A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures.\n* Korean males and females ≥ 19 and ≤ 60 years of age at the Screening visit\n\nExclusion Criteria:\n\n* Subject with a history or presence of clinically significant active diseases.\n* Subject who has participated in other clinical studies (including bioequivalence tests) within 6 months before the Screening visit and has received IPs'}, 'identificationModule': {'nctId': 'NCT04076293', 'briefTitle': 'Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects', 'orgStudyIdInfo': {'id': 'HM-GLP2-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HM15912', 'interventionNames': ['Drug: HM15912']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HM15912', 'type': 'DRUG', 'description': 'The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).', 'armGroupLabels': ['HM15912']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}