A Phase 1, First-in-Human Study of BMS-986421 in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Early Phase 1

Conditions: Healthy Participants

Treatments: Other: Placebo; Drug: BMS-986421

Study type: Interventional

Funder types: Industry

Identifiers

NCT05517837

IM052-004

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of BMS-986421 in healthy adult participants.

Enrollment: 46 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants are required to remain in the clinical facility from Day -1 (Part 1) or Day -2 (Part 2) until clinic discharge.
• 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.
• All female participants, Women of Childbearing Potential (WOCBP) and women not of childbearing potential, must have a negative highly sensitive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) at screening and on Day -1 (or Day -2 for Part 2).

Exclusion criteria

• 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).
• Vaccination or plans for vaccination with non-live vaccines within 30 days before Day -1 (for Day -2 for Part 2) until the follow-up phone call.
• Donation of blood or blood transfusion within 8 weeks of first study intervention administration.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

BMS-986421 Under Fasted Conditions

Experimental group

Treatment:

Drug: BMS-986421

Placebo

Placebo Comparator group

Treatment:

Other: Placebo