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

Healthy Participants Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06084598
• Other study ID #: CN008-0016
• Status: Completed
• Phase: Phase 1
• Start date: October 12, 2023
• Est. completion date: March 8, 2024

Study information

• Verified date: March 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 8, 2024
• Est. primary completion date: March 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986446
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		Up to Day 85
Primary	Number of participants with vital sign abnormalities		Up to Day 85
Primary	Number of participants with electrocardiogram (ECG) abnormalities		Up to Day 85
Primary	Number of participants with physical examination abnormalities		Up to Day 85
Primary	Number of participants with body weight abnormalities		Up to Day 85
Primary	Number of participants with clinical laboratory abnormalities		Up to Day 85
Secondary	Maximum observed plasma concentration (Cmax)		Up to Day 85
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to Day 85
Secondary	Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)]		Up to Day 85
Secondary	Number of participants with anti-drug antibody (ADA)		Up to Day 85
Secondary	Geometric mean ratios of Cmax		Up to Day 85
Secondary	Geometric mean ratios of [AUC(0-T)]		Up to Day 85
Secondary	Geometric mean ratios of area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]		Up to Day 85

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting