A Randomized, Double-Blind, Parallel-Group, Phase 1 Clinical Trial Comparing the Pharmacokinetic, Safety, and Immunogenicity of the Biosimilar HS016 and the Originator Adalimumab in Chinese Healthy Male Subjects.

ABSTRACT: A comparison of the immunogenicity, safety, and pharmacokinetic properties of HS016 and its originator, adalimumab, was conducted in Chinese healthy male subjects. This was a phase 1 single-center, randomized, parallel-group double-blind clinical trial. Chinese healthy male subjects (1:1) allocated to HS016 and adalimumab groups were treated with single subcutaneous injections (40 mg/0.8 mL). The pharmacokinetic equivalence of HS016 and adalimumab was assessed by (1) the area under the plasma concentration-time curve (AUC) from time 0 to the last detectable drug concentration (AUC_0-t ), (2) the AUC from time 0 extrapolated to infinity (AUC_0-∞ ), and (3) the maximum plasma concentration (C_max ). Other pharmacokinetic parameters (time to C_max , app

SUBMITTER: Cao G 

PROVIDER: S-EPMC7984335 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature