Completed
PHASE1
INTERVENTIONAL
NCT04905667
Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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 ®.
Detailed Description
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.
Interventions
Name:
GB221
Type:
DRUG
Description:
6 mg/kg, single dose, intravenous infusion, 90-100 min
Name:
Herceptin
Type:
DRUG
Description:
6 mg/kg, single dose, intravenous infusion, 90-100 min
Primary Outcomes
Measure:
AUC0-t
TimeFrame:
Day 43
Description:
compare the pharmacokinetic AUC0-t parameters of GB221 and Herceptin ®
Measure:
AUC0-∞
TimeFrame:
Day 43
Description:
compare the pharmacokinetic AUC0-∞parameters of GB221 and Herceptin ®
Measure:
Cmax
TimeFrame:
Day 43
Description:
compare the pharmacokinetic Cmax parameters of GB221 and Herceptin ®
Trial Information
NCT ID
NCT04905667
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Genor Biopharma Co., Ltd.
Last Updated
December 15, 2025