Trials / Completed
CompletedNCT05995691
Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 179 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABP 501 | SC injection |
| DRUG | Adalimumab | SC injection |
Timeline
- Start date
- 2014-11-24
- Primary completion
- 2015-12-04
- Completion
- 2015-12-04
- First posted
- 2023-08-16
- Last updated
- 2023-08-16
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05995691. Inclusion in this directory is not an endorsement.