Clinical trial NCT06955741: A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants
Official title: A Phase 1, Randomized, Open-label, Parallel, Single-dose Study to Assess the Pharmacokinetics, Tolerability, and Absolute Bioavailability of Subcutaneous Administration of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Bioavailability Study
Subcutaneous Injection
Anti-MTBR Tau Monoclonal Antibody
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-05-02
Enrollment: 46
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 assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants


Eligibility criteria: 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.

Primary outcomes:
measure: Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC
timeFrame: Up to approximately Day 85
measure: 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
timeFrame: Up to approximately Day 85
measure: 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
timeFrame: Up to approximately Day 85
measure: Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion
timeFrame: Up to approximately Day 85
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to approximately Day 85
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to approximately Day 85
measure: Number of Participants With AEs Reported Related to BMS-986446
timeFrame: Up to approximately Day 85
measure: Number of Participants With Clinically Significant Vital Sign Abnormalities
timeFrame: Up to approximately Day 85
measure: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
timeFrame: Up to approximately Day 85
measure: Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities
timeFrame: Up to approximately Day 85
measure: Number of Participants With Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to approximately Day 85
measure: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
timeFrame: Up to approximately Day 85
measure: Cmax of BMS-986446
timeFrame: Up to approximately Day 85
measure: AUC(0-T) of BMS-986446
timeFrame: Up to approximately Day 85
measure: AUC(0-672) of BMS-986446
timeFrame: Up to approximately Day 85
measure: Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986446
timeFrame: Up to approximately Day 85
measure: Time of Maximum Observed Serum Concentration (Tmax) of BMS-986446
timeFrame: Up to approximately Day 85
measure: Apparent Terminal Serum Half-life (T-HALF) of BMS-986446
timeFrame: Up to approximately Day 85
measure: Total Body Clearance in IV Infusion (CLT) of BMS-986446
timeFrame: Up to approximately Day 85
measure: Apparent Total Body Clearance in SC Administration (CLT/F) of BMS-986446
timeFrame: Up to approximately Day 85
measure: Volume of Distribution of Terminal Phase in IV Infusion (Vz) of BMS-986446
timeFrame: Up to approximately Day 85
measure: Apparent Volume of Distribution of Terminal Phase in SC Administration (Vz/F) of BMS-986446
timeFrame: Up to approximately Day 85
measure: Number of Participants With Anti-drug Antibody Development
timeFrame: Up to approximately Day 85
measure: Local Tolerance Evaluation SC Administration of BMS-986646 Assessed by Questionnaire
timeFrame: Up to approximately Day 85
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC (ACT)
state: California
city: Anaheim
country: United States
facility: Local Institution - 10000
state: California
city: Anaheim
country: United States
facility: Local Institution - 9999
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: