Skip to main content
OpenTrials
Completed

NCT Number: NCT06086886

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0002, London, Greater London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examinations, 12-lead ECGs, and clinical laboratory tests obtained during the screening period.
  • Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
  • A negative test for COVID-19, which will be performed in the manner mandated by the clinical site where this study is being conducted, at screening and admission.

Exclusion criteria

  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.
  • Participant was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
  • Inability to be venipunctured or tolerate venous access.

Note: Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986454

Drug

Specified dose on specified days

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 4 months

  2. Number of participants with severe adverse events (SAEs)

    Time frame: Up to approximately 4 months

  3. Number of participants with physical examination abnormalities

    Time frame: Up to approximately 4 months

  4. Number of participants with vital sign abnormalities

    Time frame: Up to approximately 4 months

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to approximately 4 months

  6. Number of participants with clinical laboratory abnormalities

    Time frame: Up to approximately 4 months

Secondary outcomes

  1. Maximum observed serum concentration (Cmax)

    Time frame: Up to approximately 3 months

  2. Time of maximum observed serum concentration (Tmax)

    Time frame: Up to approximately 3 months

  3. Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)]

    Time frame: Up to approximately 3 months

  4. Incidence of anti-drug antibody (ADA) formation

    Time frame: Up to approximately 3 months

  5. Absolute Bioavailability (F) of BMS-986454

    Time frame: Up to approximately 3 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.