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

NCT06086886 | Completed Phase 1 FDA Drug

• 2 other identifiers: IM055-1001U1111-1270-3670
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Participants

Keywords

Pharmacokinetics; Pharmacodynamics; Healthy Participants; BMS-986454; First-in-human; Safety

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

• Absolute Bioavailability (F) of BMS-986454

  Up to approximately 3 months

Study Arms (2)

BMS-986454

EXPERIMENTAL

Drug: BMS-986454

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

BMS-986454 DRUG

Specified dose on specified days

BMS-986454

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0002

London, Greater London, NW10 7EW, United Kingdom

Location

Local Institution - 0001

Nottingham, NG11 6JS, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: November 16, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)