drugset / Trial / NCT04820439

Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection

NCT04820439

Phase 1 Completed 88 enrolled The Affiliated Hospital of Qingdao University
RandomizedParallel-groupOpen-labelOther

Summary

This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.

Timeline

Start
2020-10-13
Primary completion
2021-02-01
Completion
2021-03-13

Drugs

EvaluationDrugModalityDoseRoute
Subject HS627 Monoclonal antibody 420 mg Intravenous
Comparator Pertuzumab Monoclonal antibody 420 mg Intravenous

Indications

No indication recorded.