Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT‐P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects

Abstract

Aims To evaluate pharmacokinetic equivalence and preliminary safety of the adalimumab biosimilar CT‐P17 administered via autoinjector (CT‐P17 AI) or prefilled syringe (CT‐P17 PFS) in healthy subjects. Methods This phase I, open‐label study ( ClinicalTrials.gov : NCT04295356) randomised subjects (1:1) to receive a single 40‐mg (100 mg/mL) dose of CT‐P17 AI or CT‐P17 PFS. Primary endpoint was pharmacokinetic equivalence of CT‐P17 AI to CT‐P17 PFS for: area under the concentration–time curve from time zero to infinity (AUC 0–inf ); area under the concentration–time curve from time zero to the last quantifiable concentration (AUC 0–last ); maximum serum concentration (C max ). Equivalence was determined if the 90% confidence interval for the geometric least‐squares mean ratio was within the 80–125% equivalence margin. Additional pharmacokinetic endpoints, safety and immunogenicity were evaluated. Results Of 193 subjects who were randomised (98 CT‐P17 AI; 95 CT‐P17 PFS), 180 received study drug. Pharmacokinetic equivalence was demonstrated: 90% confidence intervals were within the 80–125% equivalence margin (AUC 0–inf : 93.98–114.29; AUC 0–last : 91.09–121.86; C max : 94.08–111.90). Mean serum CT‐P17 concentrations, secondary pharmacokinetic parameters and numbers of subjects with antidrug antibodies (ADAs) or neutralising ADAs were comparable between groups. AUC 0–inf , AUC 0–last and C max were numerically lower for ADA‐positive than for ADA‐negative subjects (both groups); pharmacokinetic equivalence was also demonstrated among ADA‐positive subjects. CT‐P17 AI and CT‐P17 PFS were well tolerated, with comparable overall safety profiles. Conclusions CT‐P17 AI and CT‐P17 PFS were pharmacokinetically equivalent. Overall safety and immunogenicity were comparable between the 2 delivery devices.