Trials / Completed
CompletedNCT05800418
Clinical Study to Compare the Pharmacokinetics and Safety of Ramucirumab Injection With Cyramza ® in Healthy Male Volunteers
Phase I Clinical Study of Single-center, Randomized, Double-blind, Single-dose, Parallel Comparison of the Pharmacokinetics and Safety of Ramucirumab Injection and Cyramza® in Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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®.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ramucirumab Injection | Ramucirumab injection biosimilar products manufactured by Chia Tai Tianqing Pharmaceutical, |
| DRUG | Ramucirumab Injection [Cyramza] | Ramucirumab Injection is a humanized monoclonal antibody based on the human immunoglobulin G1(IgG1) skeleton sequence, developed by Eli Lilly Co., the bran name is Cyramza. Ramucirumab is a vascular endothelial growth factor receptor 2 (VEGFR2) antagonist that specifically binds to VEGF receptor 2 and blocks VEGFR ligand, VEGF-A, VEGF-C, and VEGF-D binding to the receptor. As a result, Ramucirumab inhibits ligand-stimulated VEGF receptor 2 activation, thereby inhibiting ligand-induced proliferation, and human endothelial cell migration. Ramucirumab inhibits angiogenesis, thereby blocking the tumor's blood vessel supply. |
Timeline
- Start date
- 2019-11-04
- Primary completion
- 2020-02-18
- Completion
- 2020-02-18
- First posted
- 2023-04-05
- Last updated
- 2023-04-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05800418. Inclusion in this directory is not an endorsement.