[Translation] A randomized, double-blind, single-dose, parallel comparison of the pharmacokinetic characteristics of humanized anti-VEGF monoclonal antibody injection and bevacizumab injection (Avastin) in healthy Chinese male volunteers
主要研究目的:比较试验药物人源化抗VEGF单抗注射液(规格:100mg/4mL,北京赛升药业股份有限公司生产)和对照药物贝伐珠单抗注射液[Avastin,安维汀,规格: 100mg/4mL,Roche Diagnostics GmbH生产(欧洲来源),北京赛升药业股份有限公司提供]在中国健康男性志愿者以 1mg/kg单次静脉滴注给药的药代动力学(PK)相似性。次要研究目的:评价人源化抗VEGF单抗注射液和贝伐珠单抗注射液(Avastin,安维汀)在中国健康男性志愿者单次静脉滴注给药的安全性、耐受性和免疫原性。
[Translation] The primary study objective was to compare the pharmacokinetic (PK) similarity of the experimental drug humanized anti-VEGF monoclonal antibody injection (specification: 100 mg/4 mL, produced by Beijing Saisheng Pharmaceutical Co., Ltd.) and the control drug bevacizumab injection [Avastin, specification: 100 mg/4 mL, produced by Roche Diagnostics GmbH (European source), provided by Beijing Saisheng Pharmaceutical Co., Ltd.] in healthy Chinese male volunteers after a single intravenous drip of 1 mg/kg. The secondary study objective was to evaluate the safety, tolerability and immunogenicity of humanized anti-VEGF monoclonal antibody injection and bevacizumab injection (Avastin) in healthy Chinese male volunteers after a single intravenous drip.