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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-16

Study Completion Date

2024-12-20

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BMS-986454

Group Type EXPERIMENTAL

BMS-986454

Intervention Type DRUG

Specified dose on specified days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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BMS-986454

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes