Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-03 @ 6:47 PM
Study NCT ID:
NCT06843460
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2025-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C542017', 'term': 'ACE-011'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The first 12 participants were randomized 1:3 between placebo or 0.3 mg/kg of sotatercept. After those 12 participants were complete, the next 12 were randomized 1:3 between placebo or 0.7 mg/kg of sotatercept.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-02-20', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 120 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.'}, {'measure': 'Number of Participants Who Discontinue Study Due to an AE', 'timeFrame': 'Up to approximately 120 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.'}, {'measure': 'Maximum Serum Concentration (Cmax) of Sotatercept', 'timeFrame': 'At designated timepoints (up to 120 days)', 'description': 'Blood samples will be collected to determine the Cmax of sotatercept.'}, {'measure': 'Time to Maximum Serum Concentration (Tmax) of Sotatercept', 'timeFrame': 'Predose and at designated timepoints up to 120 days postdose', 'description': 'Blood samples will be collected to determine the Tmax of sotatercept.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-7962', 'timeFrame': 'At designated timepoints (up to 120 days)', 'description': 'Blood samples will be collected to determine the AUC0-last of MK-7962.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7962', 'timeFrame': 'At designated timepoints (up to 120 days)', 'description': 'Blood samples will be collected to determine the AUC0-inf of MK-7962.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to 28 days (AUC0-28 days) of MK-7962', 'timeFrame': 'At designated timepoints (up to 28 days postdose)', 'description': 'Blood samples will be collected to determine the AUC0-28 days of MK-7962.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of MK-7962', 'timeFrame': 'At designated timepoints (up to 120 days)', 'description': 'Blood samples will be collected to determine the t1/2 of MK-7962.'}, {'measure': 'Apparent Clearance (CL/F) of MK-7962', 'timeFrame': 'At designated timepoints (up to 120 days)', 'description': 'Blood samples will be collected to determine the CL/F of MK-7962.'}, {'measure': 'Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-7962', 'timeFrame': 'At designated timepoints (up to 120 days)', 'description': 'Blood samples will be collected to determine the Vz/F of MK-7962.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to learn about the safety of 2 different amounts of sotatercept and if healthy Chinese people tolerate them. The study will also measure what happens to sotatercept in a person's body over time (pharmacokinetic or PK study)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is in good health\n* Has a BMI≥18.0 kg/m\\^2 and ≤28.0 kg/m\\^2\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* Has been treated with a sotatercept or luspatercept'}, 'identificationModule': {'nctId': 'NCT06843460', 'briefTitle': 'A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Sotatercept (MK-7962) in Healthy Chinese Participants', 'orgStudyIdInfo': {'id': '7962-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sotatercept Dose Level 1', 'description': 'Participants received a single dose of sotatercept at dose level 1.', 'interventionNames': ['Biological: Sotatercept']}, {'type': 'EXPERIMENTAL', 'label': 'Sotatercept Dose Level 2', 'description': 'Participants received a single dose of sotatercept at dose level 2.', 'interventionNames': ['Biological: Sotatercept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received a single dose of placebo to sotatercept.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Sotatercept', 'type': 'BIOLOGICAL', 'otherNames': ['MK-7962', 'ActRIIA-IgG1Fc', 'ACE-011'], 'description': 'Single subcutaneous injection', 'armGroupLabels': ['Sotatercept Dose Level 1', 'Sotatercept Dose Level 2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Single subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}