A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986454 in Healthy Participants

Last updated: March 21, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

BMS-986454

Placebo

Clinical Study ID

NCT06086886
IM055-1001
U1111-1270-3670
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to assess the safety and tolerability of BMS-986454 in healthy adult participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female participants who are healthy as determined by the investigator basedon review of medical history, physical examinations, 12-lead ECGs, and clinicallaboratory tests obtained during the screening period.

  • Participant is willing and able to adhere to the study visit schedule and otherprotocol requirements.

  • A negative test for COVID-19, which will be performed in the manner mandated by theclinical site where this study is being conducted, at screening and admission.

Exclusion

Exclusion Criteria:

  • Evidence of organ dysfunction or any clinically significant deviation from normal inphysical examination, vital signs, 12-lead ECG, or clinical laboratory tests beyondwhat is consistent with a healthy population in the region in which the study isconducted.

  • Participant was exposed to an investigational drug (new chemical entity) within 30days preceding the first dose administration, or 5 half-lives of thatinvestigational drug, if known (whichever is longer).

  • Inability to be venipunctured or tolerate venous access.

Note: Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 63
Treatment Group(s): 2
Primary Treatment: BMS-986454
Phase: 1
Study Start date:
November 16, 2023
Estimated Completion Date:
December 20, 2024

Connect with a study center

  • Hammersmith Medicines Research Limited

    London, Greater London NW10 7EW
    United Kingdom

    Active - Recruiting

  • Local Institution - 0002

    London, Greater London NW10 7EW
    United Kingdom

    Site Not Available

  • Local Institution - 0001

    Nottingham, NG11 6JS
    United Kingdom

    Site Not Available

  • Quotient Sciences Nottingham

    Nottingham, NG11 6JS
    United Kingdom

    Active - Recruiting

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