A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants
Study Details
To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and maximum observed serum concentration (Cmax) in healthy adult participants.
Protocol Summary
AUCinf of ABP 501-HCF and ABP 501-LCF
Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
Cmax of ABP 501-HCF and ABP 501-LCF
Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
AUC from Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of ABP 501-HCF and ABP 501-LCF
Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
Time at which Cmax is Observed (Tmax) of ABP 501-HCF and ABP 501-LCF
Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
Terminal Elimination Half-life (t1/2) of ABP 501-HCF and ABP 501-LCF
Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
Apparent Clearance (CL/F) of ABP 501-HCF and ABP 501-LCF
Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
Apparent Volume of Distribution (Vz/F) of ABP 501-HCF and ABP 501-LCF
Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
Mean Residence Time (MRT) of ABP 501-HCF and ABP 501-LCF
Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Day 1 until Day 63
Number of Participants with an Event of Interest
Timeframe: Day 1 until Day 63
Number of Participants with Binding and Neutralizing Anti-drug Antibodies
Timeframe: Pre-dose Day 1, Day 16, Day 29, and Day 63