Clinical trial NCT06084598: A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986446 in Healthy Participants and Healthy Participants of Japanese Ethnicity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Pharmacokinetics
Healthy Participants
Healthy Japanese Participants
BMS-986446
PRX005
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-10-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to Day 85
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 85
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 85
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 85
measure: Number of participants with body weight abnormalities
timeFrame: Up to Day 85
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 85
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 85
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to Day 85
measure: Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)]
timeFrame: Up to Day 85
measure: Number of participants with anti-drug antibody (ADA)
timeFrame: Up to Day 85
measure: Geometric mean ratios of Cmax
timeFrame: Up to Day 85
measure: Geometric mean ratios of [AUC(0-T)]
timeFrame: Up to Day 85
measure: Geometric mean ratios of area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
timeFrame: Up to Day 85
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Local Institution - 0001
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: