NCT07780383 · Bristol-Myers Squibb
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
What this study is about
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
View original scientific description
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
Interventions
DRUG
BMS-986446
Specified dose on specified days
Primary outcome measures
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
Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after intravenous (IV) infusion
Time frame: Up to approximately 5 months
Maximum observed concentration (Cmax)
Time frame: Up to approximately 5 months
Time of maximum observed concentration (Tmax)
Time frame: Up to approximately 5 months
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
Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672))
Time frame: Up to approximately 5 months
AUC(INF)
Time frame: Up to approximately 5 months
Half-life (T-HALF)
Time frame: Up to approximately 5 months
Apparent total body clearance in SC administration (CLT/F)
Time frame: Up to approximately 5 months
Total body clearance in IV infusion (CLT)
Time frame: Up to approximately 5 months
Apparent volume of distribution of terminal phase in SC administration (Vz/F)
Time frame: Up to approximately 5 months
Volume of distribution of terminal phase (VZ)
Time frame: Up to approximately 5 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Anaheim, California
- Bradenton, Florida
- Daytona Beach, Florida
- Naples, Florida
- The Villages, Florida
- Decatur, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2026 · Source of record for eligibility and locations