A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants
Phase 1
Active, not 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
- ACTIVE_NOT_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 Clinically Significant Laboratory Assessment Abnormalities 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 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 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.
Number of Participants With Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) 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 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 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
Trial Locations
- Locations (2)
Local Institution - 0001
🇺🇸Anaheim, California, United States
Local Institution - 10000
🇺🇸Anaheim, California, United States
Local Institution - 0001🇺🇸Anaheim, California, United States