[Translation] A randomized, double-blind, parallel-controlled phase I clinical trial comparing the pharmacokinetic characteristics of recombinant humanized anti-VEGF monoclonal antibody (JY028) injection and Avastin® in healthy subjects
主要目的:以北京东方百泰生物科技有限公司生产的重组人源化抗 VEGF 单克隆抗体(JY028)注射液为受试制剂,以 Roche Diagnostics GmbH 生产的安维汀®为参比制剂,比较两制剂在健康受试者体内的主要药代动力学参数,评价两制剂药代动力学的相似性。
次要目的:评价两制剂在健康受试者体内的安全性和免疫原性。
[Translation] Main purpose: Take the recombinant humanized anti-VEGF monoclonal antibody (JY028) injection produced by Beijing Dongfang Baitai Biotechnology Co., Ltd. as the test preparation, and use Avastin® produced by Roche Diagnostics GmbH as the reference preparation to compare the two. The main pharmacokinetic parameters of the preparations in healthy subjects were evaluated to evaluate the similarity of the pharmacokinetics of the two preparations.
Secondary objective: To evaluate the safety and immunogenicity of both formulations in healthy subjects.