Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-01-01 @ 12:50 AM
Study NCT ID:
NCT06821334
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2025-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Dose Study of MK-6194 in Healthy Chinese Participants (MK-6194-014)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to 42 days post dose', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 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 42 days post dose', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of MK-6194', 'timeFrame': 'Up to 42 days post dose', 'description': 'Blood samples will be collected at specified intervals to determine the AUC0-last of MK-6194.'}, {'measure': 'Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194', 'timeFrame': 'Up to 42 days post dose', 'description': 'Blood samples will be collected at specified intervals to determine the AUC0-inf of MK-6194.'}, {'measure': 'Maximum Serum Concentration (Cmax) of MK-6194', 'timeFrame': 'Up to 42 days post dose', 'description': 'Blood samples will be collected at specified intervals to determine the Cmax of MK-6194.'}, {'measure': 'Time to Maximum Serum Concentration (Tmax) of MK-6194', 'timeFrame': 'Up to 42 days post dose', 'description': 'Blood samples will be collected at specified intervals to determine the Tmax of MK-6194.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of MK-6194', 'timeFrame': 'Up to 42 days post dose', 'description': 'Blood samples will be collected at specified intervals to determine the t1/2 of MK-6194.'}, {'measure': 'Apparent Clearance (CL/F) of MK-6194', 'timeFrame': 'Up to 42 days post dose', 'description': 'Blood samples will be collected at specified intervals to determine the CL/F of MK-6194.'}, {'measure': 'Apparent Volume of Distribution during terminal phase (Vz/F) of MK-6194', 'timeFrame': 'Up to 42 days post dose', 'description': 'Blood samples will be collected at specified intervals to determine the Vz/F of MK-6194.'}, {'measure': 'Incidence of Antidrug Antibodies (ADA) to MK-6194', 'timeFrame': 'Up to 42 days post dose', 'description': 'Blood samples will be collected at specified intervals to determine the ADA response to MK-6194.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to learn how safe MK-6194 is in healthy Chinese adults and how well people tolerate it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe key inclusion criteria include but are not limited to the following:\n\n* Is in good health\n* Has body mass index (BMI) within 18.0 to 28.0 kg/m\\^2 (inclusive) and weight ≥50 kg\n\nExclusion Criteria:\n\nThe key exclusion criteria include but are not limited to the following:\n\n* History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* Has a history of opportunistic infection, Human immunodeficiency virus (HIV), hepatitis B, hepatitis C, tuberculosis'}, 'identificationModule': {'nctId': 'NCT06821334', 'briefTitle': 'A Single Dose Study of MK-6194 in Healthy Chinese Participants (MK-6194-014)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics of MK-6194 in Healthy Chinese Participants', 'orgStudyIdInfo': {'id': '6194-014'}, 'secondaryIdInfos': [{'id': 'MK-6194-014', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A', 'description': 'Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 1) or Placebo.', 'interventionNames': ['Biological: MK-6194', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B', 'description': 'Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 2) or Placebo.', 'interventionNames': ['Biological: MK-6194', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel C', 'description': 'Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 3) or Placebo.', 'interventionNames': ['Biological: MK-6194', 'Biological: Placebo']}], 'interventions': [{'name': 'MK-6194', 'type': 'BIOLOGICAL', 'description': 'Subcutaneous Administration', 'armGroupLabels': ['Panel A', 'Panel B', 'Panel C']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Subcutaneous administration', 'armGroupLabels': ['Panel A', 'Panel B', 'Panel C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital (Site 0001)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], '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'}}}}