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Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects

NCT ID: NCT02145234

Last Updated: 2017-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Primary Purpose - other: Protocol designed to assess the safety, tolerability, immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-986089 in healthy subjects

Enrollment: Single ascending dose panels: 48 subjects, Multiple ascending dose panels: 96

Minimum age: 18 years (Elderly MAD Panel 65 years of age) Maximum age: 55 years (Elderly MAD Panel 70 years of age)

Conditions

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Healthy Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAD Panel 1:BMS-986089/Placebo

BMS-986089 in a single subcutaneous administration

OR

Placebo matching with BMS-986089 in a single subcutaneous administration

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

SAD Panel 2:BMS-986089/Placebo

BMS-986089 in a single subcutaneous administration

OR

Placebo matching with BMS-986089 in a single subcutaneous administration

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

SAD Panel 3:BMS-986089/Placebo

BMS-986089 in a single subcutaneous administration

OR

Placebo matching with BMS-986089 in a single subcutaneous administration

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

SAD Panel 4:BMS-986089/Placebo

BMS-986089 in a single subcutaneous administration

OR

Placebo matching with BMS-986089 in a single subcutaneous administration

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

SAD Panel 5:BMS-986089/Placebo

BMS-986089 in a single subcutaneous administration

OR

Placebo matching with BMS-986089 in a single subcutaneous administration

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

MAD Panel 1:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 multiple subcutaneous administrations weekly

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

MAD Panel 2:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

MAD Panel 3:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

MAD Panel 4:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

MAD Panel 5:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administration every 2 weeks

OR

Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

MAD Panel 6:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

MAD Panel 7:BMS-986089/Placebo

BMS-986089 a single subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 a single subcutaneous administration every 2 weeks

Group Type EXPERIMENTAL

BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

Interventions

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BMS-986089

Intervention Type DRUG

Placebo matching with BMS-986089

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations
* Men and women who are not of childbearing potential (ie, who are postmenopausal or Surgically sterile WOCBP) ages 21 to 55 years
* Women must not be breastfeeding
* 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

Exclusion Criteria

* Any significant acute or chronic medical illness Any major surgery within 6 weeks of study drug administration
* Any condition that will clearly require medical or surgical treatment during the period of study participation
* Any bone trauma or bone surgery within 3 months of study drug administration
* Known or suspected autoimmune disorder
* Donation of blood or plasma to a blood bank or in a clinical study (except at screening visit) within 6 weeks of study
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Wcct Global, Llc

Cypress, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38190001 (View on PubMed)

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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CN001-001

Identifier Type: -

Identifier Source: org_study_id

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