This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
88
A single intravenous infusion of HS627 420mg
A single intravenous infusion of Perjeta ®420mg
Phase I Clinical Research Center
Qingdao, Shandong, China
Area under the plasma concentration versus time curve (AUC)0-∞
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 150 days
Area under the plasma concentration versus time curve (AUC)0-t
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Time frame: 150 days
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Time frame: 150 days
The total clearance(CL)
Evaluation of the total clearance(CL)
Time frame: 150 days
elimination half-life time(T1/2)
Evaluation of elimination half-life time(T1/2)
Time frame: 150 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.