Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT02145234
Status:
COMPLETED
Last Update Posted:
2017-09-07
First Post:
2014-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-05', 'studyFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2014-05-20', 'lastUpdatePostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety endpoints, including incidence of Adverse Event (AEs), serious AEs, AEs leading to discontinuation or death, as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations', 'timeFrame': 'Single Ascending Dose (SAD) Phase 119 days'}, {'measure': 'Safety endpoints, including incidence of Adverse Event (AEs), serious AEs, AEs leading to discontinuation or death, as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations', 'timeFrame': 'Multiple Ascending Dose (MAD) phase 148 days'}], 'secondaryOutcomes': [{'measure': 'Maximum observed serum concentration (Cmax) for SAD and MAD', 'timeFrame': 'SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120'}, {'measure': 'Time of maximum observed serum concentration (Tmax) for SAD and MAD', 'timeFrame': 'SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120'}, {'measure': 'Serum concentration 168 h post dose (C(168H)) for SAD and MAD', 'timeFrame': 'SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120'}, {'measure': 'Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) for SAD', 'timeFrame': 'SAD phase: Day1 to Day 91'}, {'measure': 'Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) for SAD', 'timeFrame': 'SAD phase: Day1 to Day 91'}, {'measure': 'Apparent total body clearance (CLT/F) for SAD', 'timeFrame': 'SAD phase: Day1 to Day 91'}, {'measure': 'Volume of distribution of terminal phase (if IV and if multi-exponential decline) (Vz/F) for SAD', 'timeFrame': 'SAD phase: Day1 to Day 91'}, {'measure': 'Half life (T-Half) for SAD and MAD', 'timeFrame': 'SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120'}, {'measure': 'Serum concentration 336 h post dose (C(336H)) for SAD and MAD', 'timeFrame': 'SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120'}, {'measure': 'Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) for MAD', 'timeFrame': 'MAD phase: Day 1 to Day 120'}, {'measure': 'Area under the concentration-time curve in one dosing interval (AUC(TAU)) for MAD', 'timeFrame': 'MAD phase: Day 1 to Day 120'}, {'measure': 'Degree of Fluctuation or Fluctuation Index (DF) for MAD', 'timeFrame': 'MAD phase: Day 1 to Day 120'}, {'measure': 'Average concentration over a dosing interval (Css-Avg) for MAD', 'timeFrame': 'MAD phase: Day 1 to Day 120'}, {'measure': 'AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI AUC) for MAD', 'timeFrame': 'MAD phase: Day 1 to Day 120'}, {'measure': 'Cmax Accumulation Index; ratio of Cmax at steady-state to Cmax after the first dose (AI Cmax) for MAD', 'timeFrame': 'MAD phase: Day 1 to Day 120'}, {'measure': 'C(168H) Accumulation Index; ratio of C168H at steady-state to C168H after the first dose (AI C168H) for MAD', 'timeFrame': 'MAD phase: Day 1 to Day 120'}, {'measure': 'C(336H) Accumulation Index; ratio of C(336H) at steady-state to C(336H) after the first dose (AI 336H) for MAD', 'timeFrame': 'MAD phase: Day 1 to Day 120'}, {'measure': 'Immunogenicity of single and multiple doses of BMS-986089 will be measured by testing for the presence of ADAs for SAD and MAD', 'timeFrame': '30 days'}, {'measure': 'The pharmacodynamic effect of single and multiple doses of BMS-986089 on free myostatin, total myostatin (pre-dose only), and myostatin-drug complex will be assessed by measuring these biomarkers for SAD and MAD', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Adults']}, 'referencesModule': {'references': [{'pmid': '38190001', 'type': 'DERIVED', 'citation': 'Muntoni F, Byrne BJ, McMillan HJ, Ryan MM, Wong BL, Dukart J, Bansal A, Cosson V, Dreghici R, Guridi M, Rabbia M, Staunton H, Tirucherai GS, Yen K, Yuan X, Wagner KR; Taldefgrobep Alfa Study Group. The Clinical Development of Taldefgrobep Alfa: An Anti-Myostatin Adnectin for the Treatment of Duchenne Muscular Dystrophy. Neurol Ther. 2024 Feb;13(1):183-219. doi: 10.1007/s40120-023-00570-w. Epub 2024 Jan 8.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects.', 'detailedDescription': 'Primary Purpose - other: Protocol designed to assess the safety, tolerability, immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-986089 in healthy subjects\n\nEnrollment: Single ascending dose panels: 48 subjects, Multiple ascending dose panels: 96\n\nMinimum age: 18 years (Elderly MAD Panel 65 years of age) Maximum age: 55 years (Elderly MAD Panel 70 years of age)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations\n* Men and women who are not of childbearing potential (ie, who are postmenopausal or Surgically sterile WOCBP) ages 21 to 55 years\n* Women must not be breastfeeding\n* Men who are sexually active with women of child bearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness Any major surgery within 6 weeks of study drug administration\n* Any condition that will clearly require medical or surgical treatment during the period of study participation\n* Any bone trauma or bone surgery within 3 months of study drug administration\n* Known or suspected autoimmune disorder\n* Donation of blood or plasma to a blood bank or in a clinical study (except at screening visit) within 6 weeks of study'}, 'identificationModule': {'nctId': 'NCT02145234', 'briefTitle': 'Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'CN001-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAD Panel 1:BMS-986089/Placebo', 'description': 'BMS-986089 in a single subcutaneous administration\n\nOR\n\nPlacebo matching with BMS-986089 in a single subcutaneous administration', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Panel 2:BMS-986089/Placebo', 'description': 'BMS-986089 in a single subcutaneous administration\n\nOR\n\nPlacebo matching with BMS-986089 in a single subcutaneous administration', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Panel 3:BMS-986089/Placebo', 'description': 'BMS-986089 in a single subcutaneous administration\n\nOR\n\nPlacebo matching with BMS-986089 in a single subcutaneous administration', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Panel 4:BMS-986089/Placebo', 'description': 'BMS-986089 in a single subcutaneous administration\n\nOR\n\nPlacebo matching with BMS-986089 in a single subcutaneous administration', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Panel 5:BMS-986089/Placebo', 'description': 'BMS-986089 in a single subcutaneous administration\n\nOR\n\nPlacebo matching with BMS-986089 in a single subcutaneous administration', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Panel 1:BMS-986089/Placebo', 'description': 'BMS-986089 in multiple subcutaneous administrations weekly\n\nOR\n\nPlacebo matching with BMS-986089 multiple subcutaneous administrations weekly', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Panel 2:BMS-986089/Placebo', 'description': 'BMS-986089 in multiple subcutaneous administrations weekly\n\nOR\n\nPlacebo matching with BMS-986089 in multiple subcutaneous administrations weekly', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Panel 3:BMS-986089/Placebo', 'description': 'BMS-986089 in multiple subcutaneous administrations weekly\n\nOR\n\nPlacebo matching with BMS-986089 in multiple subcutaneous administrations weekly', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Panel 4:BMS-986089/Placebo', 'description': 'BMS-986089 in multiple subcutaneous administrations weekly\n\nOR\n\nPlacebo matching with BMS-986089 in multiple subcutaneous administrations weekly', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Panel 5:BMS-986089/Placebo', 'description': 'BMS-986089 in multiple subcutaneous administration every 2 weeks\n\nOR\n\nPlacebo matching with BMS-986089 in multiple subcutaneous administrations weekly', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Panel 6:BMS-986089/Placebo', 'description': 'BMS-986089 in multiple subcutaneous administrations weekly\n\nOR\n\nPlacebo matching with BMS-986089 in multiple subcutaneous administrations weekly', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Panel 7:BMS-986089/Placebo', 'description': 'BMS-986089 a single subcutaneous administrations weekly\n\nOR\n\nPlacebo matching with BMS-986089 a single subcutaneous administration every 2 weeks', 'interventionNames': ['Drug: BMS-986089', 'Drug: Placebo matching with BMS-986089']}], 'interventions': [{'name': 'BMS-986089', 'type': 'DRUG', 'armGroupLabels': ['MAD Panel 1:BMS-986089/Placebo', 'MAD Panel 2:BMS-986089/Placebo', 'MAD Panel 3:BMS-986089/Placebo', 'MAD Panel 4:BMS-986089/Placebo', 'MAD Panel 5:BMS-986089/Placebo', 'MAD Panel 6:BMS-986089/Placebo', 'MAD Panel 7:BMS-986089/Placebo', 'SAD Panel 1:BMS-986089/Placebo', 'SAD Panel 2:BMS-986089/Placebo', 'SAD Panel 3:BMS-986089/Placebo', 'SAD Panel 4:BMS-986089/Placebo', 'SAD Panel 5:BMS-986089/Placebo']}, {'name': 'Placebo matching with BMS-986089', 'type': 'DRUG', 'armGroupLabels': ['MAD Panel 1:BMS-986089/Placebo', 'MAD Panel 2:BMS-986089/Placebo', 'MAD Panel 3:BMS-986089/Placebo', 'MAD Panel 4:BMS-986089/Placebo', 'MAD Panel 5:BMS-986089/Placebo', 'MAD Panel 6:BMS-986089/Placebo', 'MAD Panel 7:BMS-986089/Placebo', 'SAD Panel 1:BMS-986089/Placebo', 'SAD Panel 2:BMS-986089/Placebo', 'SAD Panel 3:BMS-986089/Placebo', 'SAD Panel 4:BMS-986089/Placebo', 'SAD Panel 5:BMS-986089/Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'Wcct Global, Llc', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}