Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

Healthy Male Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005455
• Other study ID #: CIBI305K101
• Status: Completed
• Phase: Phase 1
• Start date: July 30, 2021
• Est. completion date: January 28, 2022

Study information

• Verified date: June 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;

• Age=18 years and =50 years, healthy male subjects;

• Weight = 50kg and = 100kg,BMI= 19kg/m2 and < 28 kg/m2

• Clinical examinations in the screening period are normal or abnormal without clinical significance.

• Agree to take effective contraceptive measures throughout the study period and until at least 6 months after receiving the last dose of study drug

Exclusion Criteria:

1. Any prior VEGF(vascular endothelial growth factor) and VEGFR(Vascular Endothelial Growth Factor Receptor) antibody or protein treatment within one year.

2. Serious, non-healing wound, active ulcer, or untreated bone fracture, or major surgical procedure within 2 months prior to randomization or anticipation of need for major surgery during the course of the study or 2 months after end of the study.

3. Use Rx or OTC drugs or nutritional health products within 5 half-lives or within 2 weeks before the first dose of study drug (According to the longer time).Herbal supplements need to stop at 28 days before the first dose of study drug.

4. Positive hepatitis b surface antigen (HBsAg), hepatitis c virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody or syphilis.

5. Known hypersensitivity to bevacizumab or any excipients, known allergic disease or allergic constitution.

6. History of blood donation within 3 months before the first dose of study drug.

7. Treatment with any other investigational agent or participation in another clinical trial within 3 months prior to screening.

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• bevacizumab with new manufacturing process.
3mg/kg,I.V.,single dose
• bevacizumab with old manufacturing process.
3mg/kg,I.V.,single dose

Locations

Country	Name	City	State
China	The first affiliated hospital of Soochow university	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure:Area Under the Curve(AUC0-8)		84days
Secondary	Area Under the Curve(AUClast)		84days
Secondary	Maximum Concentration (Cmax)		84days
Secondary	Volume of distribution (V)		84days
Secondary	Total body clearance (CL)		84days
Secondary	Elimination half-life (t1/2)		84days
Secondary	Time at which maximum concentration occurred (Tmax)		2016days
Secondary	Incicende of Adverse Events (AEs)		98days
Secondary	Anti-drug Antibody(ADA)and Neutralizing Antibody(NAb)		98days