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

A Phase 1, Randomized, Multi-Part, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986421 in Healthy Participants

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05517837

Enrollment

Registered

2022-08-26

Start date

2022-09-13

Completion date

2023-07-14

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

BMS-986421, Safety, Tolerability, Dose Escalation

Brief summary

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

Interventions

DRUGBMS-986421

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number of participants with clinical laboratory abnormalities	Up to 8 Weeks
Number of participants with physical examination abnormalities	Up to 8 Weeks
Number of participants with vital sign abnormalities	Up to 8 Weeks
Number of participants with electrocardiogram (ECG) abnormalities	Up to 8 Weeks
Number of participants with adverse events (AEs)	Up to 8 Weeks

Secondary

Measure	Time frame
Area under the plasma concentration-time curve from time zero to time last quantifiable concentration (AUC[0-T])	Up to 192 hours after each dose
Time of maximum observed plasma concentration (Tmax)	Up to 192 hours after each dose
Maximum observed plasma concentration (Cmax)	Up to 192 hours after each dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026