drugset / Trial / NCT04905667

Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®

NCT04905667

Phase 1 Completed 87 enrolled Genor Biopharma Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

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 ®.

Timeline

Start
2019-11-13
Primary completion
2020-09-08
Completion
2020-09-11

Drugs

EvaluationDrugModalityDoseRoute
Subject GB221 Monoclonal antibody 6 mg/kg Intravenous
Comparator Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications