[Translation] A randomized, double-blind, parallel-controlled Phase I study comparing the pharmacokinetics, safety, and immunogenicity of CMAB820 injection versus KEYTRUDA® in healthy adult male subjects after a single dose
主要目的
比较CMAB820注射液和可瑞达®在健康成年男性受试者中单次给药的药代动力学(PK)特征的相似性
次要目的
比较CMAB820注射液和可瑞达®在健康成年男性受试者中单次给药的安全性和免疫原性
比较CMAB820注射液和可瑞达®在健康成年男性受试者中单次给药的药效学特征
[Translation] Primary objective
To compare the similarity of the pharmacokinetic (PK) characteristics of CMAB820 injection and Keytruda® in healthy adult male subjects after a single dose
Secondary objective
To compare the safety and immunogenicity of CMAB820 injection and Keytruda® in healthy adult male subjects after a single dose
To compare the pharmacodynamic characteristics of CMAB820 injection and Keytruda® in healthy adult male subjects after a single dose