Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

NCT ID: NCT05005455

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-30
• Study Completion Date: 2022-01-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

bevacizumab with old manufacturing process.

Group Type: ACTIVE_COMPARATOR

bevacizumab with old manufacturing process.

Intervention Type: DRUG

3mg/kg,I.V.,single dose

bevacizumab with new manufacturing process.

Group Type: EXPERIMENTAL

bevacizumab with new manufacturing process.

Intervention Type: DRUG

3mg/kg,I.V.,single dose

Interventions

bevacizumab with new manufacturing process.

3mg/kg,I.V.,single dose

Intervention Type: DRUG

bevacizumab with old manufacturing process.

3mg/kg,I.V.,single dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first affiliated hospital of Soochow university

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

CIBI305K101

Identifier Type: -

Identifier Source: org_study_id