This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and Herceptin ®.
Subjects will enroll in random order, and be divided into two groups, then receive a single dose (6 mg/kg) of GB221 or Herceptin ®, and accept observation for 42 days. Throughout the course, safety data will be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
87
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou, China
AUC0-t
compare the pharmacokinetic AUC0-t parameters of GB221 and Herceptin ®
Time frame: Day 43
AUC0-∞
compare the pharmacokinetic AUC0-∞parameters of GB221 and Herceptin ®
Time frame: Day 43
Cmax
compare the pharmacokinetic Cmax parameters of GB221 and Herceptin ®
Time frame: Day 43
Tmax
compare the pharmacokinetic Tmax parameters of GB221 and Herceptin ®
Time frame: Day 43
t1/2
compare the pharmacokinetic t1/2 parameters of GB221 and Herceptin ®
Time frame: Day 43
CL
compare the pharmacokinetic CL parameters of GB221 and Herceptin ®
Time frame: Day 43
Vd
compare the pharmacokinetic Vd parameters of GB221 and Herceptin ®
Time frame: Day 43
Ke
compare the pharmacokinetic Ke parameters of GB221 and Herceptin ®
Time frame: Day 43
ADA
compare the incidence of ADA in of GB221 and Herceptin ® group
Time frame: Day 43
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Nab
compare the incidence of Nab in of GB221 and Herceptin ® group
Time frame: Day 43