NCT03390673

To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Prestige Biopharma Limited · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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..

Detailed description

This is a double-blind, randomized, three-arm, parallel-group, single-dose study. A total of 120 evaluable subjects are required.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	HD204	Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
DRUG	Avastin	Single-Dose 1mg/kg body weight by 90 minute intravenous infusion

Timeline

• Start date: 2018-09-19
• Primary completion: 2019-03-13
• Completion: 2019-03-13
• First posted: 2018-01-04
• Last updated: 2024-11-19

Locations

2 sites across 1 country: New Zealand