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

Study Overview
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986454
* Other: Placebo


Participation Criteria
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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. Note: Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986454<br> | Drug: BMS-986454<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to approximately 4 months | 
| Number of participants with severe adverse events (SAEs) |  | Up to approximately 4 months | 
| Number of participants with physical examination abnormalities |  | Up to approximately 4 months | 
| Number of participants with vital sign abnormalities |  | Up to approximately 4 months | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to approximately 4 months | 
| Number of participants with clinical laboratory abnormalities |  | Up to approximately 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) |  | Up to approximately 3 months | 
| Time of maximum observed serum concentration (Tmax) |  | Up to approximately 3 months | 
| Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)] |  | Up to approximately 3 months | 
| Incidence of anti-drug antibody (ADA) formation |  | Up to approximately 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Pharmacodynamics, Healthy Participants, BMS-986454, First-in-human, Safety