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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05005455
Other study ID # CIBI305K101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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