单中心、随机、单次给药、平行对照比较IA001注射液和雅美罗在中国健康男性志愿者的药代和安全性相似性的研究
[Translation] A single-center, randomized, single-dose, parallel-controlled study comparing the pharmacokinetic and safety similarities of IA001 injection and Actemra in healthy male volunteers in China
本试验的主要目的是考察受试制剂托珠单抗(IA001注射液)的药代动力学特征,并以Roche Pharma Ltd的托珠单抗注射液为参比制剂,比较健康男性受试者静脉滴注两制剂的主要药代动力学参数,评价两制剂的药代动力学相似性。 次要目的比较受试制剂托珠单抗(IA001注射液)和参比制剂雅美罗®在健康男性受试者中单次给予4mg/kg的安全性和临床免疫原性。
[Translation] The primary purpose of this trial is to investigate the pharmacokinetic characteristics of the test preparation Tocilizumab (IA001 injection), and to compare the main pharmacokinetic parameters of the two preparations by intravenous infusion in healthy male subjects with Tocilizumab injection of Roche Pharma Ltd as the reference preparation, and to evaluate the pharmacokinetic similarity of the two preparations. The secondary purpose is to compare the safety and clinical immunogenicity of the test preparation Tocilizumab (IA001 injection) and the reference preparation Actemra® in healthy male subjects after a single administration of 4 mg/kg.
100 Clinical Results associated with Shanghai Destiny BIOTECH Co., Ltd.
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