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

NCT05800418 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2023-04-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05800418 on ClinicalTrials.gov