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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Healthy Participants

Treatments

Drug: BMS-986454
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06086886
U1111-1270-3670 (Registry Identifier)
IM055-1001

Details and patient eligibility

About

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

Enrollment

63 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

63 participants in 2 patient groups, including a placebo group

BMS-986454
Experimental group
Treatment:
Drug: BMS-986454
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

2

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Central trial contact

BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

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