NCT05476341

A Phase I Clinical Trial of Bevacizumab Injection

A Randomized, Double-blind, Single Dose, Parallel Comparison of Bevacizumab Injection and Avastin ® Phase I Clinical Study on the Similarity of Pharmacokinetics and Safety of Traditional Chinese Medicine in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor (bevacizumab) is Avastin produced by Zhengda Tianqing Pharmaceutical Group Co., Ltd Biological similar drugs. Its mechanism is to prevent VEGF from binding to its natural receptor VEGFR, inhibit the proliferation and activation of vascular endothelial cells, and play an anti angiogenesis and anti-tumor role by binding with VEGF. A randomized, double-blind, single dose, parallel comparison of bevacizumab injection and Avastin is planned The phase I clinical study on the similarity of pharmacokinetics and safety of traditional Chinese medicine in healthy male volunteers aims to compare bevacizumab injection with Avastin The similarity of pharmacokinetics, tolerance, safety and immunogenicity.

Conditions

• Rectal Cancer
• Lung Cancer
• Ovarian Cancer
• Cervical Cancer
• Glioblastoma

Interventions

Type	Name	Description
DRUG	Bevacizumab injection	Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor
DRUG	Bevacizumab injection（Avastin）	Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor

Timeline

• Start date: 2017-04-06
• Primary completion: 2017-08-18
• Completion: 2017-08-18
• First posted: 2022-07-27
• Last updated: 2022-07-27

Locations

1 site across 1 country: China