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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06084598

Enrollment

Registered

2023-10-16

Start date

2023-10-12

Completion date

2024-03-08

Last updated

2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Pharmacokinetics, Healthy Participants, Healthy Japanese Participants, BMS-986446, PRX005

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.

Interventions

DRUGBMS-986446

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

Measure	Time frame
Number of participants with body weight abnormalities	Up to Day 85
Number of participants with clinical laboratory abnormalities	Up to Day 85
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

Secondary

Measure	Time frame
Maximum observed plasma concentration (Cmax)	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
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026