Healthy Male Subjects
Conditions
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.
Interventions
DRUGbevacizumab with new manufacturing process.
3mg/kg,I.V.,single dose
DRUGbevacizumab with old manufacturing process.
3mg/kg,I.V.,single dose
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measure:Area Under the Curve(AUC0-∞) | 84days |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Concentration (Cmax) | 84days |
| Volume of distribution (V) | 84days |
| Total body clearance (CL) | 84days |
| Area Under the Curve(AUClast) | 84days |
| Time at which maximum concentration occurred (Tmax) | 2016days |
| Incicende of Adverse Events (AEs) | 98days |
| Anti-drug Antibody（ADA）and Neutralizing Antibody（NAb） | 98days |
| Elimination half-life (t1/2) | 84days |
Countries
China
Outcome results
None listed