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

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...