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

OBJECTIVE: To compare the pharmacokinetic (PK) profiles, immunogenicity, and safety of the proposed biosimilar IBI305 with those of bevacizumab in healthy male subjects.

DESIGN: A phase I, randomized, double-blinded, two-arm, parallel-group study.

SETTINGS: The study was conducted in The First Hospital of Jilin University, Changchun, China, from March 2017 to November 2017.

PARTICIPANTS: 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.

INTERVENTION: 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).

OUTCOME MEASURES: 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.

RESULTS: 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.

CONCLUSION: This study demonstrated the similarity of PK, immunogenicity, and safety profiles of IBI305 to those of bevacizumab.
.