drugset / Trial / NCT04175171

Clinical Trial of Comparative Study of GB221 Pharmacokinetics

NCT04175171

Phase 1 Completed 32 enrolled Genor Biopharma Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.

Timeline

Start
2011-11-07
Primary completion
2012-01-08
Completion
2012-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Coprelotamab Unknown 8 mg/kg Intravenous
Comparator Trastuzumab Monoclonal antibody 8 mg/kg Intravenous

Indications