Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Healthy Male Subjects

Treatments: Drug: bevacizumab with old manufacturing process.; Drug: bevacizumab with new manufacturing process.

Study type: Interventional

Funder types: Industry

Identifiers

NCT05005455

CIBI305K101

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

bevacizumab with old manufacturing process.

Active Comparator group

Treatment:

Drug: bevacizumab with old manufacturing process.

bevacizumab with new manufacturing process.

Experimental group

Treatment:

Drug: bevacizumab with new manufacturing process.