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A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects

NCT03776240 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-11-19

No results posted yet for this study

Summary

The purpose of the study is to demonstrate demonstrate the pharmacokinetic (PK) similarity of HD201 to the European (EU) and American (US) reference products Herceptin, following a single i.v. infusion of 6 mg/kg in healthy volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

HD201

Single-dose 6mg/kg body weight by 90 minute intravenous infusion

DRUG

EU-Herceptin

Single-dose 6mg/kg body weight by 90 minute intravenous infusion

DRUG

US-Herceptin

Single-dose 6mg/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
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-08-19
Completion
2019-08-19

Countries

  • Australia

Study Locations

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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 NCT03776240 on ClinicalTrials.gov