NCT03576651

A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers

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) in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: JHL Biotech, Inc. · Industry
• Sex: Male
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
BIOLOGICAL	JHL1149	Each patient may receive single dose of JHL1149 1mg/kg by intravenous infusion
BIOLOGICAL	Bevacizumab	Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion
BIOLOGICAL	Bevacizumab	Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion

Timeline

• Start date: 2018-03-24
• Primary completion: 2018-09-17
• Completion: 2019-12-13
• First posted: 2018-07-03
• Last updated: 2020-01-07

Locations

1 site across 1 country: Bulgaria