drugset / Trial / NCT04175158

Clinical Trial in Chinese Healthy Volunteers of GB222

NCT04175158 ↗

Phase 1 Unknown 84 enrolled Genor Biopharma Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of this study is to evaluate the similarity of the primary pharmacokinetic (PK) parameter AUC0-t of GB222 and bevacizumab after single administration; the secondary objective is to observe the safety and similarities and safety of other pharmacokinetic (PK) parameters (Cmax, AUC0-∞ etc.) and immunogenicity of GB222 and bevacizumab after single administration.

Timeline

Start
2017-04-24
Primary completion
2020-08
Completion
2020-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 1 mg/kg Intravenous
Subject GB222 Monoclonal antibody 1 mg/kg Intravenous