A phase I, randomized, double-blinded, single-dose study evaluating the pharmacokinetic equivalence of the biosimilar IBI305 and bevacizumab in healthy male subjects

To compare the pharmacokinetic (PK) profiles, immunogenicity, and safety of the proposed biosimilar IBI305 with those of bevacizumab in healthy male subjects.A phase I, randomized, double-blinded, two-arm, parallel-group study.The study was conducted in The First Hospital of Jilin University, Changchun, China, from March 2017 to November 2017.A total of 100 healthy male subjects were enrolled, with 48 in the IBI305 group and 50 in bevacizumab group included in the final analysis.In a 16-week study course, participants were randomized at a 1:1 ratio to receive intravenous administration of either a single dose of 3 mg/kg IBI305 (n = 50) or bevacizumab (n = 50).The primary endpoints were area under the concentration-time curve from zero to the time of the last measurable concentration (AUC0-t) and AUC curve from zero to infinity (AUC0-∞). The secondary endpoints include the other PK parameters, immunogenicity, and safety measurements.AUC0-t, AUC0-∞, maximum concentration observed (Cmax), half-life (T1/2), drug clearance, and volume of distribution were similar between IBI305- and bevacizumab-treated subjects. For AUC0-∞, AUC0-t, and Cmax, the 90% confidence intervals for the ratios of geometric means were fully within the range 0.80 - 1.25, confirming the bioequivalence of the two investigational agents. Furthermore, no apparent difference in adverse events was found between the two groups.This study demonstrated the similarity of PK, immunogenicity, and safety profiles of IBI305 to those of bevacizumab.