Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

NCT05005455 | Completed Phase 1

• 1 other identifier: CIBI305K101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure:Area Under the Curve(AUC0-∞)

  84days

Secondary Outcomes (8)

• 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

Study Arms (2)

bevacizumab with old manufacturing process.

ACTIVE COMPARATOR

Drug: bevacizumab with old manufacturing process.

bevacizumab with new manufacturing process.

EXPERIMENTAL

Drug: bevacizumab with new manufacturing process.

Interventions

bevacizumab with new manufacturing process. DRUG

3mg/kg,I.V.,single dose

bevacizumab with new manufacturing process.

bevacizumab with old manufacturing process. DRUG

3mg/kg,I.V.,single dose

bevacizumab with old manufacturing process.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Age≥18 years and ≤50 years, healthy male subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The first affiliated hospital of Soochow university

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2021
• First Posted: August 13, 2021
• Study Start: July 30, 2021
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)