A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants
Phase 1
Recruiting
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT06955741
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
- Participants must have a Body Mass Index (BMI) of 18.0 to 30.0 kg/m2.
- Participants must be healthy as determined by medical history, physical examination, neurological examination, vital signs, 12-lead ECG, C-SSRS, and clinical laboratory evaluations.
Exclusion Criteria
- Participants must not have clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.
- Participants must not have prior exposure to BMS-986446 (PRX005).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A BMS-986446 IV - Arm A Acetaminophen - Arm A Loratadine - Arm B BMS-986446 SC - Arm B Acetaminophen - Arm B Loratadine -
- Primary Outcome Measures
Name Time Method Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC Up to approximately Day 85 Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion Up to approximately Day 85 GMR of Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986446 Administered IV versus SC Up to approximately Day 85 GMR of Area Under the Serum Concentration-time Curve From Time Zero to 672 Hours (AUC(0-672)) of BMS-986446 Administered IV versus SC Up to approximately Day 85
- Secondary Outcome Measures
Name Time Method Number of Participants With Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Up to approximately Day 85 Number of Participants With Clinically Significant Laboratory Assessment Abnormalities Up to approximately Day 85 Cmax of BMS-986446 Up to approximately Day 85 AUC(0-T) of BMS-986446 Up to approximately Day 85 AUC(0-672) of BMS-986446 Up to approximately Day 85 Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986446 Up to approximately Day 85 Time of Maximum Observed Serum Concentration (Tmax) of BMS-986446 Up to approximately Day 85 Apparent Terminal Serum Half-life (T-HALF) of BMS-986446 Up to approximately Day 85 Total Body Clearance in IV Infusion (CLT) of BMS-986446 Up to approximately Day 85 Apparent Total Body Clearance in SC Administration (CLT/F) of BMS-986446 Up to approximately Day 85 Volume of Distribution of Terminal Phase in IV Infusion (Vz) of BMS-986446 Up to approximately Day 85 Apparent Volume of Distribution of Terminal Phase in SC Administration (Vz/F) of BMS-986446 Up to approximately Day 85 Number of Participants With Anti-drug Antibody Development Up to approximately Day 85 Number of Participants With Adverse Events (AEs) Up to approximately Day 85 Number of Participants With Serious Adverse Events (SAEs) Up to approximately Day 85 Number of Participants With AEs Reported Related to BMS-986446 Up to approximately Day 85 Number of Participants With Clinically Significant Vital Sign Abnormalities Up to approximately Day 85 Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Up to approximately Day 85 Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities Up to approximately Day 85 Local Tolerance Evaluation SC Administration of BMS-986646 Assessed by Questionnaire Up to approximately Day 85 Participant-reported response will be obtained using questionnaires that assess for pain (using a Numeric Rating Scale), itching, burning, pressure, and soreness/tenderness at the site injection.
Trial Locations
- Locations (3)
Local Institution - 10000
🇺🇸Anaheim, California, United States
Anaheim Clinical Trials LLC (ACT)
🇺🇸Anaheim, California, United States
Local Institution - 9999
🇺🇸Anaheim, California, United States