A Study Comparing SIBP-04 and Bevacizumab in Healthy Male Subjects
NCT04135898 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2023-12-29
Summary
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.
Conditions
- Healthy Male
Interventions
- DRUG
-
SIBP-04
3mg/kg, infusion in 90 minutes
- DRUG
-
3mg/kg, infusion in 90 minutes
Sponsors & Collaborators
-
Shanghai Institute Of Biological Products
lead INDUSTRY
Principal Investigators
-
Shanghai Institute Of Biological Products Co., Ltd · SINOPHARM
-
The First Affiliated Hospital · Bengbu Medical College
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-10-23
- Primary Completion
- 2020-03-16
- Completion
- 2020-03-16
Countries
- China
Study Locations
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