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

Phase 1 Completed 372 enrolled Amgen

RandomizedParallel-groupSingle-blindBasic science

Summary

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.

Timeline

Start: 2021-07-23
Primary completion: 2021-11-24
Completion: 2021-11-24

Publications

Background Chow V, Zhou M, Mytych DT, Colbert A, Miller MJ, Wala I, Sabet A, Radziszewski W. Pharmacokinetic, Safety, and Immunogenicity Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501, Adalimumab-Atto. Pharmacol Res Perspect. 2026 Apr;14(2):e70236. doi: 10.1002/prp2.70236.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous

Indications

No indication recorded.