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Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

Sponsor
Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05005455
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: bevacizumab with new manufacturing process.
  • Drug: bevacizumab with old manufacturing process.
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
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
Actual Study Start Date :
Jul 30, 2021
Actual Primary Completion Date :
Jan 28, 2022
Actual Study Completion Date :
Jan 28, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Primary Outcome Measure:Area Under the Curve(AUC0-∞) [84days]

Secondary Outcome Measures

  1. Area Under the Curve(AUClast) [84days]

  2. Maximum Concentration (Cmax) [84days]

  3. Volume of distribution (V) [84days]

  4. Total body clearance (CL) [84days]

  5. Elimination half-life (t1/2) [84days]

  6. Time at which maximum concentration occurred (Tmax) [2016days]

  7. Incicende of Adverse Events (AEs) [98days]

  8. Anti-drug Antibody（ADA）and Neutralizing Antibody（NAb） [98days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The first affiliated hospital of Soochow university Suzhou Jiangsu China 215006

Sponsors and Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier:
NCT05005455
Other Study ID Numbers:
  • CIBI305K101
First Posted:
Aug 13, 2021
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Bevacizumab

Study Results

No Results Posted as of Jun 10, 2022