A Study Comparing SIBP-04 and Bevacizumab in Healthy Male Subjects
- Sponsor
- Shanghai Institute Of Biological Products
- Study ID
- NCT04135898
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Male
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- SIBP-04 — DRUG3mg/kg, infusion in 90 minutes
- Bevacizumab — DRUG3mg/kg, infusion in 90 minutes
Study Details
This is a randomised, double-blind, positive drug parallel controlled clinical trial in China. In the trial, it is planned to enroll 88 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control.
Key Dates
- First listed
- Oct 23, 2019
- Start date
- Oct 23, 2019
- Status verified
- Dec 2023
- Primary completion
- Mar 16, 2020
- Completion
- Mar 16, 2020
Study Design
- Enrollment
- 88 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SIBP-04
- Active Comparator: Bevacizumab
Primary Outcome Measure
AUC0-t [ Time Frame: From 0 to day 71 ]