NCT05995691CompletedPhase 1
A Randomized, Single-blind, Single-dose, 2-Arm, Parallel-group Study to Determine the Pharmacokinetic Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 179
- Primary Endpoint
- Cmax of Adalimumab
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ABP 501
Experimental
Participants will receive a single dose of ABP 501
Intervention: ABP 501 (Drug)
Adalimumab
Active Comparator
Participants will receive a single dose of adalimumab
Intervention: Adalimumab (Drug)
Outcomes
Primary Outcomes
Cmax of Adalimumab
Time Frame: Day 1 to Day 63
AUCinf of ABP 501
Time Frame: Day 1 to Day 63
Cmax of ABP 501
Time Frame: Day 1 to Day 63
AUCinf of Adalimumab
Time Frame: Day 1 to Day 63
Secondary Outcomes
- 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)
- 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)
Investigators
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