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Completed

NCT Number: NCT06955741

A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants

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

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986446 IV

Drug

Specified dose on specified days was administered intravenously (IV).

BMS-986446 SC

Drug

Specified dose on specified days was administered subcutaneously (SC).

Acetaminophen

Drug

Specified dose on specified days

Loratadine

Drug

Specified dose on specified days

Primary outcomes

  1. Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC

    Time frame: Up to approximately Day 85

  2. 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

    Time frame: Up to approximately Day 85

  3. 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

    Time frame: Up to approximately Day 85

  4. Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion

    Time frame: Up to approximately Day 85

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to approximately Day 85

  2. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Up to approximately Day 85

  3. Number of Participants With AEs Reported Related to BMS-986446

    Time frame: Up to approximately Day 85

  4. Number of Participants With Clinically Significant Vital Sign Abnormalities

    Time frame: Up to approximately Day 85

  5. Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)

    Time frame: Up to approximately Day 85

  6. Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities

    Time frame: Up to approximately Day 85

  7. Number of Participants With Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to approximately Day 85

  8. Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

    Time frame: Up to approximately Day 85

  9. Cmax of BMS-986446

    Time frame: Up to approximately Day 85

  10. AUC(0-T) of BMS-986446

    Time frame: Up to approximately Day 85

  11. AUC(0-672) of BMS-986446

    Time frame: Up to approximately Day 85

  12. Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986446

    Time frame: Up to approximately Day 85

  13. Time of Maximum Observed Serum Concentration (Tmax) of BMS-986446

    Time frame: Up to approximately Day 85

  14. Apparent Terminal Serum Half-life (T-HALF) of BMS-986446

    Time frame: Up to approximately Day 85

  15. Total Body Clearance in IV Infusion (CLT) of BMS-986446

    Time frame: Up to approximately Day 85

  16. Apparent Total Body Clearance in SC Administration (CLT/F) of BMS-986446

    Time frame: Up to approximately Day 85

  17. Volume of Distribution of Terminal Phase in IV Infusion (Vz) of BMS-986446

    Time frame: Up to approximately Day 85

  18. Apparent Volume of Distribution of Terminal Phase in SC Administration (Vz/F) of BMS-986446

    Time frame: Up to approximately Day 85

  19. Number of Participants With Anti-drug Antibody Development

    Time frame: Up to approximately Day 85

  20. Local Tolerance Evaluation SC Administration of BMS-986646 Assessed by Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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