Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Study ID
- NCT05005455
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Male Subjects
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Accepted
Interventions
- bevacizumab with new manufacturing process. — DRUG3mg/kg,I.V.,single dose
- bevacizumab with old manufacturing process. — DRUG3mg/kg,I.V.,single dose
Study Details
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.
Key Dates
- First listed
- Aug 13, 2021
- Start date
- Jul 30, 2021
- Status verified
- Jun 2022
- Primary completion
- Jan 28, 2022
- Completion
- Jan 28, 2022
Study Design
- Enrollment
- 100 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Active Comparator: bevacizumab with old manufacturing process.
- Experimental: bevacizumab with new manufacturing process.
Primary Outcome Measure
Primary Outcome Measure:Area Under the Curve(AUC0-∞) [ Time Frame: 84days ]