A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers
- Sponsor
- JHL Biotech, Inc.
- Study ID
- NCT03576651
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Male Subjects
Eligibility Criteria
- Sex
- MALE
- Age
- 21 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- JHL1149 — BIOLOGICALEach patient may receive single dose of JHL1149 1mg/kg by intravenous infusion
- Bevacizumab — BIOLOGICALEach patient may receive single dose of Avastin 1mg/kg by intravenous infusion
- Bevacizumab — BIOLOGICALEach patient may receive single dose of Avastin 1mg/kg by intravenous infusion
Study Details
This is a Phase I, Double-blind, Randomized, Parallel-group, Single-dose, Three-Arm Study to Compare the Pharmacokinetics and to Evaluate the Tolerability, Safety and Immunogenicity of JHL1149 and Bevacizumab (Avastin) Sourced from the European Union (EU) and the Union States (US) in Healthy Male Volunteers
Key Dates
- First listed
- Jul 3, 2018
- Start date
- Mar 24, 2018
- Status verified
- Jan 2020
- Primary completion
- Sep 17, 2018
- Completion
- Dec 13, 2019
Study Design
- Enrollment
- 154 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: JHL1149
- Active Comparator: US-sourced-Avastin™
- Active Comparator: EU-sourced Avastin™
Primary Outcome Measure
AUC0-inf [ Time Frame: up to 71 days ]