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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
372
Participants will receive a single-dose SC injection of ABP 501-HCF.
Participants will receive a single-dose SC injection of ABP 501-LCF
WCCT Global, Inc
Cypress, California, United States
Qps-Mra, Llc
South Miami, Florida, United States
Pharmaceutical Research Associates, Inc
Salt Lake City, Utah, United States
AUCinf of ABP 501-HCF and ABP 501-LCF
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is an untoward medical occurrence in a clinical study irrespective of a causal relationship with the study treatment. The number of participants with TEAEs including serious AEs, clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests.
Time frame: Day 1 until Day 63
Number of Participants with an Event of Interest
Time frame: Day 1 until Day 63
Number of Participants with Binding and Neutralizing Anti-drug Antibodies
Time frame: Pre-dose Day 1, Day 16, Day 29, and Day 63