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

NCT03390673 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-11-19

No results posted yet for this study

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..

Conditions

  • Healthy Volunteers

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

Sponsors & Collaborators

  • Prestige Biopharma Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2019-03-13
Completion
2019-03-13

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03390673 on ClinicalTrials.gov