drugset
drugset / Trial / NCT04049409

Pharmacokinetic, Safety and Immunogenicity Study of CMAB809 and Herceptin in Healthy Volunteers

NCT04049409 ↗

Phase 1 Completed 72 enrolled Taizhou Mabtech Pharmaceutical Co.,Ltd
RandomizedParallel-groupQuadruple-blindScreening

Summary

This is a randomized, double-blinded, controlled Phase I study of CMAB809 administered by intravenous infusion. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB809 versus Trastuzumab(Herceptin) in healthy male subjects after a single dose.

Timeline

Start
2019-06-17
Primary completion
2019-11-20
Completion
2019-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject CMAB809 Unknown 6 mg/kg Intravenous
Comparator Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications

No indication recorded.