Healthy Volunteer
Conditions
Keywords
Bioavailability Study, Subcutaneous Injection, Anti-MTBR Tau Monoclonal Antibody
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
Interventions
DRUGBMS-986446 IV
Specified dose on specified days was administered intravenously (IV).
DRUGBMS-986446 SC
Specified dose on specified days was administered subcutaneously (SC).
DRUGAcetaminophen
Specified dose on specified days
DRUGLoratadine
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) 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 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 |
| Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion | Up to approximately Day 85 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Number of Participants With Adverse Events (AEs) | 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 | — |
| 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. |
| Time of Maximum Observed Serum Concentration (Tmax) 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 | — |
Countries
United States
Outcome results
None listed