NCT05005455

Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

A Randomized, Double-blind, Parallel Controlled, Single-dose Phase I Clinical Study to Evaluate Pharmacokinetic Similarity, Safety, and Immunogenicity of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic similarity of bevacizumab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of bevacizumab with different manufacturing process.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	bevacizumab with new manufacturing process.	3mg/kg,I.V.,single dose
DRUG	bevacizumab with old manufacturing process.	3mg/kg,I.V.,single dose

Timeline

• Start date: 2021-07-30
• Primary completion: 2022-01-28
• Completion: 2022-01-28
• First posted: 2021-08-13
• Last updated: 2022-06-10

Locations

1 site across 1 country: China