[Translation] A randomized, double-blind, parallel-controlled Phase I study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of CMAB807 injection after a change of manufacturing site with Prolix® in healthy adult male subjects in China
主要目的:
比较生产场地变更后的 CMAB807 注射液与普罗力®在中国成年男性健康受试者的药代动力学特征相似性。
次要目的:
比较生产场地变更后的 CMAB807 注射液与普罗力®在中国成年男性健康受试者的安全性、药效学和免疫原性相似性。
[Translation] Primary objective:
Compare the pharmacokinetic characteristics of CMAB807 injection after the change of production site and Proli® in Chinese adult male healthy subjects.
Secondary objective:
Compare the safety, pharmacodynamics and immunogenicity of CMAB807 injection after the change of production site and Proli® in Chinese adult male healthy subjects.