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NCT Number: NCT07700329

A Study to Evaluate the Blood Levels, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants

The purpose of the study is to evaluate the drug levels, safety and tolerability of BMS-986368 in healthy Chinese participants

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be healthy male or non-pregnant and non-nursing female (as assigned at birth).
  • Participants must be of Chinese ethnicity (both biological parents should be ethnically Chinese).
  • Participants must have BMI of 18.0 kg/m2 to 28.0 kg/m2, inclusive and body weight of ≥ 50 kg.

Exclusion criteria

  • Participants must not have personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Participants with a history of anxiety may be enrolled at the discretion of the investigator.
  • Participants must not have an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986368

Drug

Specified dose on specified days

BMS-986368-matching Placebo

Other

Specified dose of specified days

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to approximately Day 17

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to approximately Day 17

  3. Area under the concentration-time curve (AUC)

    Time frame: Up to approximately Day 17

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately Day 44

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to approximately Day 44

  3. Number of participants with clinically significant vital sign measurements

    Time frame: Up to approximately Day 17

  4. Number of participants with clinically significant 12-lead electrocardiogram (ECG) examinations

    Time frame: Up to approximately Day 17

  5. Number of participants with clinically significant laboratory assessments

    Time frame: Up to approximately Day 17

  6. Number of participants with treatment emergent suicidal ideation and behavious assessed by Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to approximately Day 17

  7. Number of participants with changes with anxiety as assessed by Beck Anxiety Inventory (BAI)

    Time frame: Up to approximately Day 17

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 1, Double-Blinded, Randomized, Placebo-Controlled, Two Parallel Cohort Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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