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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Specified dose on specified days
CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California, United States
RECRUITINGLocal Institution - 0003
Bradenton, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0005
Daytona Beach, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0007
Naples, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0006
The Villages, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0004
Decatur, Georgia, United States
NOT_YET_RECRUITINGAbsolute 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
Adverse events (AEs)
Time frame: Up to approximately 5 months
Serious adverse events (SAEs)
Time frame: Up to approximately 5 months
AEs reported as related to BMS-986446
Time frame: Up to approximately 5 months
Incidence of anti-drug antibody (ADA)
Time frame: Up to approximately 5 months
Local tolerance evaluation
This evaluation will assess pain, itching, burning, pressure, and soreness/tenderness (using a Numeric Rating Scale) at the injection site location.
Time frame: Up to approximately 5 months
GMR of Panel B1 vs Panel A3 for Cmax
Time frame: Up to approximately 5 months
GMR of Panel B1 vs Panel A3 for area under the concentration-time curve (AUC)
Time frame: Up to approximately 5 months
GMR of Panel B2 vs Panel A3 for Cmax
Time frame: Up to approximately 5 months
GMR of Panel B2 vs Panel A3 for AUC
Time frame: Up to approximately 5 months
Cmax
Panel B1, Panel B2, Panel C1
Time frame: Up to approximately 5 months
Tmax
Panel B1, Panel B2, Panel C1
Time frame: Up to approximately 5 months
AUC(0-T)
Panel B1, Panel B2
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Time frame: Up to approximately 5 months
AUC(0-672)
Panel B1, Panel B2
Time frame: Up to approximately 5 months
AUC(INF)
Panel B1, Panel B2
Time frame: Up to approximately 5 months
T-HALF
Panel B1, Panel B2, Panel C1
Time frame: Up to approximately 5 months
CLT/F
Panel B1, Panel B2, Panel C1
Time frame: Up to approximately 5 months
Vz/F
Panel B1, Panel B2, Panel C1
Time frame: Up to approximately 5 months
Trough observed plasma concentration (Ctrough)
Panel C1
Time frame: Up to approximately 5 months
Concentration at the end of a dosing interval (Ctau)
Panel C1
Time frame: Up to approximately 5 months
Area under the concentration-time curve within a dosing interval (AUC(TAU))
Panel C1
Time frame: Up to approximately 5 months