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COMPLETED
NCT03390673
PHASE1

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

Sponsor: Prestige Biopharma Limited

View on ClinicalTrials.gov

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..

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

119

Start Date

2018-09-19

Completion Date

2019-03-13

Last Updated

2026-06-17

Healthy Volunteers

Yes

Interventions

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

Locations (2)

Auckland Clinical Studies

Auckland, New Zealand

Christchurch Clinical Studies Trust Ltd

Christchurch, New Zealand