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

AbstractA 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 (AUC0 ‐t), (2) the AUC from time 0 extrapolated to infinity (AUC0 ‐∞), and (3) the maximum plasma concentration (Cmax). Other pharmacokinetic parameters (time to Cmax, apparent clearance, and half ‐life), safety, and immunogenicity were also evaluated. A total of 136 subjects were randomly divided into HS016 (n = 68) or adalimumab (n = 68) groups. The geometric means of AUC0 ‐t, AUC0 ‐∞, and Cmax were similar for HS016 and adalimumab. The 90%CIs of AUC0 ‐t (87.2% to 106.1%), AUC0 ‐∞ (87.4% to 108.4%), and Cmax (98.6% to 113.6%) were all within the prespecified bioequivalence criteria (80% to 125%). The incidence of treatment ‐emergent adverse events (TEAEs) was similar in both groups, with most TEAEs being mild; only 3 (4.4%) subjects in the HS016 group experienced moderate TEAEs. No significant differences in the time to Cmax, apparent clearance, half ‐life, an...
Source: Clinical Pharmacology in Drug Development - Category: Drugs & Pharmacology Authors: Tags: Original Manuscript Source Type: research