Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Male Subjects

Intervention / Treatment
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* Drug: bevacizumab with new manufacturing process.
* Drug: bevacizumab with old manufacturing process.


Participation Criteria
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Eligibility Criteria
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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: Any prior VEGF(vascular endothelial growth factor) and VEGFR(Vascular Endothelial Growth Factor Receptor) antibody or protein treatment within one year. 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. 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. Positive hepatitis b surface antigen (HBsAg), hepatitis c virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody or syphilis. Known hypersensitivity to bevacizumab or any excipients, known allergic disease or allergic constitution. History of blood donation within 3 months before the first dose of study drug. Treatment with any other investigational agent or participation in another clinical trial within 3 months prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bevacizumab with old manufacturing process.<br> | Drug: bevacizumab with old manufacturing process.<br>* 3mg/kg,I.V.,single dose<br>|
| Experimental: bevacizumab with new manufacturing process.<br> | Drug: bevacizumab with new manufacturing process.<br>* 3mg/kg,I.V.,single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome Measure:Area Under the Curve(AUC0-∞) |  | 84days | 

Secondary Outcome Measures

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