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

作者：Hong Zhang, Xiaoxue Zhu, Haijing Wei, Cuiyun Li, Hong Chen, Xiaojiao Li, Min Wu, Jingrui Liu, Guiling Chen, Hui Zhou, Shirui Zheng, Yanhua Ding · 发表于：International Journal of Clinical Pharmacology and Therapeutics · 年份：2019 · DOI：10.5414/cp203349 · 被引用次数：15 · 研究领域：Biosimilars and Bioanalytical Methods、Colorectal Cancer Treatments and Studies、Blood disorders and treatments

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 secondary endpoints include the other PK parameters, immunogenicity, and safety measurements. RESULTS: , 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.