drugset / Trial / NCT05800418
Clinical Study to Compare the Pharmacokinetics and Safety of Ramucirumab Injection With Cyramza ® in Healthy Male Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ramucirumab | Monoclonal antibody | 8 mg/kg | Intravenous |