[Translation] A single-center, randomized, double-blind, parallel, single-dose pharmacokinetic and safety comparison study of CMAB806 and Actamerol in healthy male volunteers in China
主要目的:观察CMAB806药代动力学特征,并以Chugai Pharma Manufacturing Co.,Ltd.生产的托珠单抗注射液(雅美罗®)为参比制剂,比较两制剂主要药代动力学参数,评价两制剂的药代动力学相似性。次要目的:比较CMAB806和雅美罗®在中国健康男性志愿者中单次静脉滴注给予4 mg/kg 的安全性和耐受性以及两制剂在中国健康男性受试者中单次静脉滴注给予4 mg/kg 的临床免疫原性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of CMAB806, and to compare the main pharmacokinetic parameters of the two preparations with tocilizumab injection (Acmero®) produced by Chugai Pharma Manufacturing Co., Ltd. as the reference preparation, and to evaluate the pharmacokinetic similarity of the two preparations. Secondary objective: To compare the safety and tolerability of CMAB806 and Actemro® in Chinese healthy male volunteers after a single intravenous infusion of 4 mg/kg, and the clinical immunogenicity of the two preparations in Chinese healthy male subjects after a single intravenous infusion of 4 mg/kg.