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NCT Number: NCT07780383

A Study to Evaluate the Drug Levels, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 in Healthy Adults After Single-dose Administration, and Participants With Early Alzheimer's Disease After Multiple Dose Administration

The purpose of this study is to evaluate the drug levels, absolute bioavailability, safety, tolerability, and immunogenicity of single-Dose of BMS-986446 in healthy adults after single-dose administration, and participants with early Alzheimer's Disease after multiple dose administration

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Anaheim, California, 92801, United States

Location contact

Site 0001

CONTACT

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must have a BMI of 18.0 to 35.0 kg/m2.
  • For Parts A and B: Participants must be healthy as determined by medical history, Physical Examination (PE), neurological examination, vital signs, 12-lead ECG, Columbia Suicide-Severity Rating Scale (C-SSRS), and clinical laboratory evaluations.
  • For Part C: Participants must meet diagnostic criteria for MCI or mild AD dementia, consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) diagnostic criteria.
  • For Part C: Participants must have an Mini Mental State Examination (MMSE) score of ≥ 20 to 28 (inclusive).
  • For Part C: Participants must have evidence of positive plasma pTau217.

Exclusion criteria

  • For Parts A and B: Participants must not have a general history of any 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.
  • For Parts A and B: Participants must not have donated or lost 500 mL blood or more within 60 days prior to study intervention administration.
  • For Part C: Participants must not have a neurological condition that in the opinion of the investigator may be contributing to cognitive impairment aside from the AD diagnosis, including but not limited to: Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, long COVID, or baseline intellectual disability.
  • For Part C: Participants must not have any current primary psychiatric diagnosis (eg, major depression, schizoaffective disorder or bipolar disorder) other than AD or symptoms (eg, hallucination or delusions).
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986446

Drug

Specified dose on specified days

Other names: PRX005, Moponetug

Primary outcomes

  1. Absolute bioavailability estimated from geometric mean ratio (GMR) of area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986446 after subcutaneous (SC) infusion

    Time frame: Up to approximately 5 months

  2. Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after intravenous (IV) infusion

    Time frame: Up to approximately 5 months

  3. Maximum observed concentration (Cmax)

    Time frame: Up to approximately 5 months

  4. Time of maximum observed concentration (Tmax)

    Time frame: Up to approximately 5 months

  5. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to approximately 5 months

  6. Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672))

    Time frame: Up to approximately 5 months

  7. AUC(INF)

    Time frame: Up to approximately 5 months

  8. Half-life (T-HALF)

    Time frame: Up to approximately 5 months

  9. Apparent total body clearance in SC administration (CLT/F)

    Time frame: Up to approximately 5 months

  10. Total body clearance in IV infusion (CLT)

    Time frame: Up to approximately 5 months

  11. Apparent volume of distribution of terminal phase in SC administration (Vz/F)

    Time frame: Up to approximately 5 months

  12. Volume of distribution of terminal phase (VZ)

    Time frame: Up to approximately 5 months

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: Up to approximately 5 months

  2. Serious adverse events (SAEs)

    Time frame: Up to approximately 5 months

  3. AEs reported as related to BMS-986446

    Time frame: Up to approximately 5 months

  4. Incidence of anti-drug antibody (ADA)

    Time frame: Up to approximately 5 months

  5. Local tolerance evaluation

    Time frame: Up to approximately 5 months

    This evaluation will assess pain, itching, burning, pressure, and soreness/tenderness (using a Numeric Rating Scale) at the injection site location.

  6. GMR of Panel B1 vs Panel A3 for Cmax

    Time frame: Up to approximately 5 months

  7. GMR of Panel B1 vs Panel A3 for area under the concentration-time curve (AUC)

    Time frame: Up to approximately 5 months

  8. GMR of Panel B2 vs Panel A3 for Cmax

    Time frame: Up to approximately 5 months

  9. GMR of Panel B2 vs Panel A3 for AUC

    Time frame: Up to approximately 5 months

  10. Cmax

    Time frame: Up to approximately 5 months

    Panel B1, Panel B2, Panel C1

  11. Tmax

    Time frame: Up to approximately 5 months

    Panel B1, Panel B2, Panel C1

  12. AUC(0-T)

    Time frame: Up to approximately 5 months

    Panel B1, Panel B2

  13. AUC(0-672)

    Time frame: Up to approximately 5 months

    Panel B1, Panel B2

  14. AUC(INF)

    Time frame: Up to approximately 5 months

    Panel B1, Panel B2

  15. T-HALF

    Time frame: Up to approximately 5 months

    Panel B1, Panel B2, Panel C1

  16. CLT/F

    Time frame: Up to approximately 5 months

    Panel B1, Panel B2, Panel C1

  17. Vz/F

    Time frame: Up to approximately 5 months

    Panel B1, Panel B2, Panel C1

  18. Trough observed plasma concentration (Ctrough)

    Time frame: Up to approximately 5 months

    Panel C1

  19. Concentration at the end of a dosing interval (Ctau)

    Time frame: Up to approximately 5 months

    Panel C1

  20. Area under the concentration-time curve within a dosing interval (AUC(TAU))

    Time frame: Up to approximately 5 months

    Panel C1

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Open-label, Multi-part Study to Evaluate Pharmacokinetics, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 Following Intravenous and Subcutaneous Administrations in Healthy Adults and Multiple Doses of BMS-986446 in Participants With Early Alzheimer's Disease.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

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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