Clinical Trials in the USA / NCT07780383
Recruiting
Phase 1
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
NCT07780383 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Alzheimer's DiseaseHealthy Participants
Study summary
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
Eligibility
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.
Primary outcome measure(s)
- 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 — Up to approximately 5 months
- Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after intravenous (IV) infusion — Up to approximately 5 months
- Maximum observed concentration (Cmax) — Up to approximately 5 months
- Time of maximum observed concentration (Tmax) — Up to approximately 5 months
- Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) — Up to approximately 5 months
- Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672)) — Up to approximately 5 months
- AUC(INF) — Up to approximately 5 months
- Half-life (T-HALF) — Up to approximately 5 months
- Apparent total body clearance in SC administration (CLT/F) — Up to approximately 5 months
- Total body clearance in IV infusion (CLT) — Up to approximately 5 months
- Apparent volume of distribution of terminal phase in SC administration (Vz/F) — Up to approximately 5 months
- Volume of distribution of terminal phase (VZ) — Up to approximately 5 months
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| CenExel ACT (Formerly Anaheim Clinical Trials; LLC) | Anaheim | California | Recruiting |
| Local Institution - 0003 | Bradenton | Florida | Not Yet Recruiting |
| Local Institution - 0005 | Daytona Beach | Florida | Not Yet Recruiting |
| Local Institution - 0007 | Naples | Florida | Not Yet Recruiting |
| Local Institution - 0006 | The Villages | Florida | Not Yet Recruiting |
| Local Institution - 0004 | Decatur | Georgia | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07780383 on ClinicalTrials.gov ↗ ← All trials in the USA