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Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

NCT05005455 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-06-10

No results posted yet for this study

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

Interventions

DRUG

bevacizumab with new manufacturing process.

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

DRUG

bevacizumab with old manufacturing process.

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

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2022-01-28
Completion
2022-01-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05005455 on ClinicalTrials.gov