At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Double-blind, Randomised, Single-dose, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating HD204 and Avastin for Healthy Volunteers. Completed, enrolled 119 participants across 2 sites.
Detailed Summary
The purpose of this study is to compare the pharmacokinetics, as well as to evaluate the safety, tolerability and immunogenicity of HD204, US-Avastin and EU-Avastin in healthy male subjects after intravenous administration of a single dose..
Study Details
Timeline
Arms & Interventions
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Interventions
Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Single-Dose 1mg/kg body weight by 90 minute intravenous infusion