drugset / Trial / NCT05800418

Clinical Study to Compare the Pharmacokinetics and Safety of Ramucirumab Injection With Cyramza ® in Healthy Male Volunteers

NCT05800418

Phase 1 Completed 88 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Ramucirumab is a biosimilar drug of CYRAMZA® produced by Chiatai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., LTD. It is a vascular endothelial growth factor receptor 2 (VEGFR-2) antagonist. This single-center, randomized, double-blind, single-dose, parallel phase I study of Ramucirumab injection versus Cyramza ® in healthy male volunteers was designed to evaluate the similarities in pharmacokinetics, tolerance, safety and immunogenicity of Ramucirumab and CYRAMZA®.

Timeline

Start
2019-11-04
Primary completion
2020-02-18
Completion
2020-02-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramucirumab Monoclonal antibody 8 mg/kg Intravenous