Clinical trial NCT05005455: Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-13
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Primary Outcome Measure:Area Under the Curve(AUC0-∞)
timeFrame: 84days
Secondary outcomes:
measure: Area Under the Curve(AUClast)
timeFrame: 84days
measure: Maximum Concentration (Cmax)
timeFrame: 84days
measure: Volume of distribution (V)
timeFrame: 84days
measure: Total body clearance (CL)
timeFrame: 84days
measure: Elimination half-life (t1/2)
timeFrame: 84days
measure: Time at which maximum concentration occurred (Tmax)
timeFrame: 2016days
measure: Incicende of Adverse Events (AEs)
timeFrame: 98days
measure: Anti-drug Antibody（ADA）and Neutralizing Antibody（NAb）
timeFrame: 98days
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The first affiliated hospital of Soochow university
state: Jiangsu
Study officials:
References: