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
← catalyst calendarNCT07780383 · readout in 299 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 1
Status
Not yet recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
84estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-21
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-08-21 | estimated | When the study began enrolling |
| Primary completion | 2027-06-17 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-06-17 | estimated | The whole study's end, after follow-up |
| First posted | 2026-08-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Alzheimer's Disease
- Healthy Participants
Intervention
- Drug: BMS-986446 — also filed as PRX005, Moponetug
Primary outcomes
what the primary-completion date above is the date OFAbsolute 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
measured Up to approximately 5 months
Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after intravenous (IV) infusion
measured Up to approximately 5 months
Maximum observed concentration (Cmax)
measured Up to approximately 5 months
Time of maximum observed concentration (Tmax)
measured Up to approximately 5 months
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
measured Up to approximately 5 months
Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672))
measured Up to approximately 5 months
AUC(INF)
measured Up to approximately 5 months
Half-life (T-HALF)
measured Up to approximately 5 months
Apparent total body clearance in SC administration (CLT/F)
measured Up to approximately 5 months
Total body clearance in IV infusion (CLT)
measured Up to approximately 5 months
Apparent volume of distribution of terminal phase in SC administration (Vz/F)
measured Up to approximately 5 months
Volume of distribution of terminal phase (VZ)
measured Up to approximately 5 months
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