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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Other: Placebo; Drug: BMS-986446

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Other: Placebo; Specified dose on specified days
Experimental: BMS-986446	Drug: BMS-986446; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs)	Up to Day 85
Number of participants with vital sign abnormalities	Up to Day 85
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 85
Number of participants with physical examination abnormalities	Up to Day 85
Number of participants with body weight abnormalities	Up to Day 85
Number of participants with clinical laboratory abnormalities	Up to Day 85

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to Day 85
Time of maximum observed plasma concentration (Tmax)	Up to Day 85
Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)]	Up to Day 85
Number of participants with anti-drug antibody (ADA)	Up to Day 85
Geometric mean ratios of Cmax	Up to Day 85
Geometric mean ratios of [AUC(0-T)]	Up to Day 85
Geometric mean ratios of area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]	Up to Day 85

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Actual): March 8, 2024
• Study Completion (Actual): March 8, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy Participants; Healthy Japanese Participants; BMS-986446; PRX005
• Other Study ID Numbers: CN008-0016; 2022-001827-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No