Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: bevacizumab with old manufacturing process.; Drug: bevacizumab with new manufacturing process.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • the First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bevacizumab with old manufacturing process.	Drug: bevacizumab with old manufacturing process.; 3mg/kg,I.V.,single dose
Experimental: bevacizumab with new manufacturing process.	Drug: bevacizumab with new manufacturing process.; 3mg/kg,I.V.,single dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: July 17, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: CIBI305K101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No