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Completed

NCT Number: NCT05005455

Study 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.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The first affiliated hospital of Soochow university

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

bevacizumab with new manufacturing process.

Drug

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

bevacizumab with old manufacturing process.

Drug

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

Primary outcomes

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

    Time frame: 84days

Secondary outcomes

  1. Area Under the Curve(AUClast)

    Time frame: 84days

  2. Maximum Concentration (Cmax)

    Time frame: 84days

  3. Volume of distribution (V)

    Time frame: 84days

  4. Total body clearance (CL)

    Time frame: 84days

  5. Elimination half-life (t1/2)

    Time frame: 84days

  6. Time at which maximum concentration occurred (Tmax)

    Time frame: 2016days

  7. Incicende of Adverse Events (AEs)

    Time frame: 98days

  8. Anti-drug Antibody(ADA)and Neutralizing Antibody(NAb)

    Time frame: 98days

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2021
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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