Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants
- Registration Number
- NCT05995691
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to determine the bioequivalence of ABP 501 (subcutaneous \[SC\] injection) compared to adalimumab (SC injection) as assessed principally by the area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf), and maximum observed serum concentration (Cmax) in Japanese participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABP 501 ABP 501 Participants will receive a single dose of ABP 501 Adalimumab Adalimumab Participants will receive a single dose of adalimumab
- Primary Outcome Measures
Name Time Method Cmax of Adalimumab Day 1 to Day 63 AUCinf of ABP 501 Day 1 to Day 63 Cmax of ABP 501 Day 1 to Day 63 AUCinf of Adalimumab Day 1 to Day 63
- Secondary Outcome Measures
Name Time Method t1/2 of Adalimumab Day 1 to Day 63 Time at Which the Maximum Observed Serum Concentration is Observed (Tmax) of ABP 501 Day 1 to Day 63 Tmax of Adalimumab Day 1 to Day 63 Area Under the Serum Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUClast) of ABP 501 Day 1 to Day 63 AUClast of Adalimumab Day 1 to Day 63 Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Day 1 to Day 63 Any clinically significant changes in vital signs or clinical laboratory test results after the dose of treatment will be recorded as TEAEs.
Number of Participants With Anti-drug Antibodies (ADA) Day 1 to Day 63 Terminal Phase Elimination Half-life (t1/2) of ABP 501 Day 1 to Day 63