Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-03 @ 8:04 PM
Study NCT ID:
NCT06843993
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2025-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-Ascending Dose Study of MK-2060 in Healthy Chinese Male Adult Participants (MK-2060-009)
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': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who experience one or more adverse events (AEs)', 'timeFrame': 'Up to 164 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.'}, {'measure': 'Number of participants who discontinue study due to an AE', 'timeFrame': 'Up to 164 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.'}, {'measure': 'Number of participants who experience one or more AEs related to bleeding', 'timeFrame': 'Up to 164 days', 'description': 'A bleeding related AE includes any sign or symptom of bleeding even if not requiring intervention by a medical/ healthcare professional, to clinically-relevant non major bleeding or major bleeding.'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration at end of infusion (Ceoi) of MK-2060', 'timeFrame': 'Predose Day 1 and end of infusion', 'description': 'Ceoi is defined as the amount of MK-2060 in plasma following IV infusion administration of MK-2060. Blood samples were collected at pre-specified time points to assess Ceoi.'}, {'measure': 'Plasma concentration at 168 hours (C168hr) of MK-2060', 'timeFrame': 'At designated timepoints (up to 168 hours)', 'description': 'C168 is defined as the maximum concentration of MK-2060 reached at 168 hours postdose. Blood samples were collected at pre-specified time points to assess C168hr.'}, {'measure': 'Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-2060', 'timeFrame': 'At designated timepoints (up to 150 days)', 'description': 'AUC0-inf is defined as the area under the concentration-time curve of MK-2060 from time zero to infinity. Blood samples were collected at pre-specified time points to assess AUC0-inf.'}, {'measure': 'AUC from 0 to 168 hours (AUC0-168) of MK-2060', 'timeFrame': 'At designated timepoints (up to 168 hours)', 'description': 'AUC0-168 is defined as the area under the concentration-time curve of MK-2060 from time zero to 168 hours. Blood samples were collected at pre-specified time points to assess AUC0-168.'}, {'measure': 'Time to maximum observed plasma drug concentration (Tmax) of MK-2060', 'timeFrame': 'At designated timepoints (up to 150 days)', 'description': 'Tmax is defined as time to the maximum concentration of MK-2060 reached. Blood samples were collected at pre-specified time points to assess Tmax.'}, {'measure': 'Terminal half-life of MK-2060', 'timeFrame': 'At designated timepoints (up to 150 days)', 'description': 't½ is defined as the time required to divide the MK-2060 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-2060. Blood samples were collected at pre-specified time points to assess terminal half-life.'}, {'measure': 'Clearance (CL) of MK-2060', 'timeFrame': 'At designated timepoints (up to 150 days)', 'description': 'CL is the volume of plasma from which MK-2060 is completely removed per unit time. Blood samples were collected at pre-specified time points to assess CL.'}, {'measure': 'Volume of distribution (Vz) of MK-2060', 'timeFrame': 'At designated timepoints (up to 150 days)', 'description': 'Vz is defined as the distributed volume of MK-2060 in plasma. Blood samples were collected at pre-specified time points to assess Vz.'}, {'measure': 'Change from baseline in activated partial thromboplastin time (aPTT)', 'timeFrame': 'Baseline (pre-dose) Day 1 and at designated timepoints (up to 150 days)', 'description': 'Blood samples were collected at pre-specified time points to assess change from baseline in aPTT.'}, {'measure': 'Anti-drug antibodies (ADA) positive incidence', 'timeFrame': 'At designated timepoints (up to 150 days)', 'description': 'Blood samples were collected at pre-specified time points to assess the incidence of anti-MK-2060 antibodies.'}, {'measure': 'Factor XI (FXI) activity level', 'timeFrame': 'At designated timepoints (up to 150 days)', 'description': 'Blood samples were collected at pre-specified time points to assess FXI activity level.'}, {'measure': 'Prothrombin time (PT)', 'timeFrame': 'At designated timepoints (up to 150 days)', 'description': 'Blood samples were collected at pre-specified time points to assess PT.'}]}, '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 the study is to learn about the safety of MK-2060 and if people tolerate it. Researchers also want to learn what happens to MK-2060 in a person's body over time."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe key inclusion criteria include but are not limited to the following:\n\n* Is in good health before randomization\n* Has a body mass index (BMI) ≥18 and ≤28 kg/m\\^2.\n\nExclusion Criteria:\n\nThe key exclusion criteria include but are not limited to the following:\n\n* Has a 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 cancer (malignancy)'}, 'identificationModule': {'nctId': 'NCT06843993', 'briefTitle': 'Single-Ascending Dose Study of MK-2060 in Healthy Chinese Male Adult Participants (MK-2060-009)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single-Ascending Dose Clinical Trial to Study the Safety, Pharmacokinetics and Pharmacodynamics of MK-2060 in Healthy Chinese Male Adult Participants', 'orgStudyIdInfo': {'id': '2060-009'}, 'secondaryIdInfos': [{'id': 'MK-2060-009', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A: MK-2060 Dose 1', 'description': 'MK-2060 dose 1 was administered as a single intravenous (IV) infusion dose on Day 1.', 'interventionNames': ['Biological: MK-2060']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B: MK-2060 Dose 2', 'description': 'MK-2060 dose 2 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel A and B.', 'interventionNames': ['Biological: MK-2060']}, {'type': 'EXPERIMENTAL', 'label': 'Panel C: MK-2060 Dose 3', 'description': 'MK-2060 dose 3 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel B and C.', 'interventionNames': ['Biological: MK-2060']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo was administered as a single IV infusion over MK-2060-matched time period on Day 1.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'MK-2060', 'type': 'BIOLOGICAL', 'description': 'Single doses of MK-2060 administered via IV infusion on Day 1 according to randomization.', 'armGroupLabels': ['Panel A: MK-2060 Dose 1', 'Panel B: MK-2060 Dose 2', 'Panel C: MK-2060 Dose 3']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Single doses of placebo administered via IV infusion on Day 1 according to randomization.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 001)', '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'}}}}