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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06084598
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.1
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986446; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Oct 13, 2023
• Anticipated Primary Completion Date: Feb 16, 2024
• Anticipated Study Completion Date: Feb 16, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of adverse events (AEs) [Up to Day 85]

2. Number of participants with vital sign abnormalities [Up to Day 85]

3. Number of participants with electrocardiogram (ECG) abnormalities [Up to Day 85]

4. Number of participants with physical examination abnormalities [Up to Day 85]

5. Number of participants with body weight abnormalities [Up to Day 85]

6. Number of participants with clinical laboratory abnormalities [Up to Day 85]

Secondary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Up to Day 85]

2. Time of maximum observed plasma concentration (Tmax) [Up to Day 85]

3. Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)] [Up to Day 85]

4. Number of participants with anti-drug antibody (ADA) [Up to Day 85]

5. Geometric mean ratios of Cmax [Up to Day 85]

6. Geometric mean ratios of [AUC(0-T)] [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)] [Up to Day 85]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altasciences	Cypress	California	United States	90630

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT06084598
• Other Study ID Numbers: CN008-0016; 2022-001827-34
• First Posted: Oct 16, 2023
• Last Update Posted: Oct 16, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Pharmacokinetics; Healthy Participants; Healthy Japanese Participants; BMS-986446; PRX005

Study Results

No Results Posted as of Oct 16, 2023