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

Phase 1 Completed 140 enrolled Hoffmann-La Roche

RandomizedSingle-groupDouble-blindOther

Summary

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.

Timeline

Start: 2014-06-30
Primary completion: 2016-02-29
Completion: 2016-02-29

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Taldefgrobep Alfa	Protein / enzyme biologic	—	Subcutaneous

Indications

No indication recorded.