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Completed

NCT Number: NCT06084598

A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986446 in Healthy Participants and Healthy Participants of Japanese Ethnicity

The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986446 in healthy participants including healthy participants of Japanese ethnicity.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant must be of Japanese ethnicity (both biological parents are ethnically Japanese) for Part 1 and Part 2, Panel 2. No limitations on ethnicity apply to Part 2, Panel 1
  • Participant is healthy, without any significant abnormalities in medical history, physical examination, ECGs, or clinical laboratory assessments determinations, as assessed by the investigator
  • Body mass index (BMI) of at least 18 kg/m^2 but no more than 32 kg/m^2 at screening
  • Body weight between 45 kg and 110 kg

Exclusion criteria

  • Any clinically significant deviation from normal, as judged by the investigator
  • Any major surgery within 90 days of study drug administration
  • Participation in another interventional clinical trial concurrent with this study

Note: Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986446

Drug

Specified dose on specified days

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to Day 85

  2. Number of participants with vital sign abnormalities

    Time frame: Up to Day 85

  3. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 85

  4. Number of participants with physical examination abnormalities

    Time frame: Up to Day 85

  5. Number of participants with body weight abnormalities

    Time frame: Up to Day 85

  6. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 85

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 85

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to Day 85

  3. Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)]

    Time frame: Up to Day 85

  4. Number of participants with anti-drug antibody (ADA)

    Time frame: Up to Day 85

  5. Geometric mean ratios of Cmax

    Time frame: Up to Day 85

  6. Geometric mean ratios of [AUC(0-T)]

    Time frame: Up to Day 85

  7. Geometric mean ratios of area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

    Time frame: Up to Day 85

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravenously Administered BMS-986446 in Healthy Participants Including Healthy Participants of Japanese Ethnicity

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 16, 2023
Registry last updated
Mar 15, 2024

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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