A Phase 1 Study to Evaluate Safety, Tolerability, and Drug Levels of BMS-986485 in Healthy Adult Participants

NCT07887763 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CN011-0025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of the administration of a single ascending doses of BMS-986485 in healthy adult participants.

Conditions

Healthy Volunteers

Keywords

Healthy; BMS-986485; Single ascending dose; Phase 1

Outcome Measures

Primary Outcomes (18)

• Number of participants with Treatment Emergent Adverse Events (TEAEs)

  Up to approximately Day 29

• Number of participants with Serious Adverse Events (SAEs)

  Up to approximately Day 29

• Number of participants with Vital Signs abnormalities

  Up to approximately Day 29

• Number of participants with Physical Examination abnormalities

  Up to approximately Day 29

• Number of Participants with 12-Lead Electrocardiogram (ECG) abnormalities

  Up to approximately Day 9

• Number of Participants with Holter ECG abnormalities

  Part A

  Up to Day 2

• Number of participants with Clinical Laboratory abnormalities

  Up to approximately Day 29

• Number of participants with suicidal ideation and behavior assessed by Columbia Suicide Severity Rating Scale (C-SSRS)

  Up to Day 9

• Time of maximum observed blood concentration (Tmax)

  Part B

  Up to Day 6

• Maximum observed blood concentration (Cmax)

  Part B

  Up to Day 6

• Apparent total body clearance (CL/F)

  Part B

  Up to Day 6

• Apparent volume of distribution during the terminal phase (Vz/F)

  Part B

  Up to Day 6

• Apparent Terminal Phase Half-life (T-HALF)

  Part B

  Up to Day 6

• Geometric mean ratios (GMRs) of Cmax

  Part B

  Up to Day 6

• GMRs of AUC(0-T)

  Part B

  Up to Day 6

• GMRs of AUC(INF)

  Part B

  Up to Day 6

• Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

  Part B

  Up to Day 6

• Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

  Part B

  Up to Day 6

Secondary Outcomes (7)

• Time of maximum observed blood concentration (Tmax)

  Up to Day 7

• Maximum observed blood concentration (Cmax)

  Up to Day 7

• Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

  Up to Day 7

• Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

  Up to Day 7

• Apparent total body clearance (CL/F)

  Up to Day 7

Study Arms (2)

Part A: SAD

EXPERIMENTAL

Drug: BMS-986485; Other: BMS-986485 matching placebo

Part B: Conditional rBA

EXPERIMENTAL

Drug: BMS-986485

Interventions

BMS-986485 DRUG

Specified dose on specified days

Part A: SAD; Part B: Conditional rBA

BMS-986485 matching placebo OTHER

Specified dose on specified days

Part A: SAD

Eligibility Criteria

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

You may qualify if:

• Participants must have body mass index (BMI) range of 18 to 33 kg/m2.

You may not qualify if:

• Participants must not have any significant medical condition (including but, not limited to, neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders).
• Participants mut not have any major surgery or planned surgery (except GI surgery) within 12 weeks of study intervention administration.
• Participants mut not have history of neurological condition (including stroke, traumatic brain injury, intracranial or intraspinal bleeding, or major neurological disorders).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Salt Lake City, Utah, 84124-1365, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

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 14, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 3, 2026
• Primary Completion (Estimated): June 8, 2027
• Study Completion (Estimated): June 8, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)