A Phase 1, First-in-Human Study of BMS-986454 in Healthy Participants
Research type
Research Study
Full title
A Phase 1, Double-Blinded, Randomized, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986454 in Healthy Participants
IRAS ID
1007536
Contact name
GCT-SU Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Research summary
The purpose of this study is to assess the safety and tolerability of BMS-986454 in healthy adult participants. This is the first study in which BMS-986454, an experimental drug, will be given to humans. Approximately 56 participants will take part in the study. This is a randomized study with 2 study drug arms: some participants will receive BMS-986454 and others will receive a matching placebo. The study drug or matching placebo will be given at a specified dose on specified days. This study is double-blinded; neither the participants nor the study team will know whether the participants will be receiving study drug or matching placebo until the end of the study. The collection of information in this study will take up to approximately 4 months. A very short part of that time involves an inpatient stay at a clinical research unit. The majority of the time involves outpatient visits or telephone calls to check on participant well-being. Protocol-defined inclusion/exclusion criteria apply.
REC name
North East - York Research Ethics Committee
REC reference
23/NE/0048
Date of REC Opinion
12 Oct 2023
REC opinion
Further Information Favourable Opinion