The purpose of this study is to compare the relative absorption of abatacept in healthy participants following subcutaneous (SC) administration in which the drug substance is manufactured with the current or new process.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Specified dose on specified days
Local Institution
Cypress, California, United States
Local Institution
Miami, Florida, United States
Local Institution
Las Vegas, Nevada, United States
Maximum observed serum concentration (Cmax)
Time frame: Up to Day 71
Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T))
Time frame: Up to Day 71
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))
Time frame: Up to Day 71
Number of participants with adverse events (AEs)
Time frame: Up to Month 12
Number of participants with clinical laboratory abnormalities
Time frame: Up to Month 12
Number of participants with vital sign abnormalities
Time frame: Up to Month 12
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 71
Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours))
Time frame: Up to Day 71
Serum concentration at 168 hours after dosing (C168)
Time frame: Up to Day 71
Time of maximum observed serum concentration (Tmax)
Time frame: Up to Day 71
Number of laboratory-reported positive responses of anti-abatacept antibodies
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Time frame: Up to Month 12
Number of laboratory-reported positive responses of anti-CTLA4-T antibodies
Time frame: Up to Day 71