TerminatedNCT05517837Updated Sep 13, 2023

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

An Early Phase 1 interventional study of BMS-986421 and Placebo in Healthy Participants, sponsored by Bristol-Myers Squibb. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Bristol-Myers Squibb · Early Phase 1, Interventional, and Treatment

Why this study was terminated

Adverse change in the risk/benefit.

From the registry’s dates

Primary completion was Jul 2023, 3 years 2 months ago, and no results have been posted to the registry.

Phase: Early Phase 1
Study type: Interventional
Enrollment: 46
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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

Conditions studied

Healthy Participants

Keywords

BMS-986421
Safety
Tolerability
Dose Escalation

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts 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

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.

Study design

Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 46 participants (actual)

Study arms

Experimental
BMS-986421 Under Fasted Conditions
Drug: BMS-986421
Placebo comparator
Placebo
Other: Placebo

Interventions

DrugBMS-986421
Specified dose on specified days
OtherPlacebo
Specified dose on specified days

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Local Institution - 0001
Cypress, California 90630, United States

References and documents

Individual participant data

Plan to share: No — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05517837
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Aug 26, 2022
Start date: Sep 13, 2022
Primary completion: Jul 14, 2023
Completion: Jul 14, 2023
Last update: Sep 13, 2023

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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