NCT03776240

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

A Phase I, Double-Blind, Randomised, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Prestige Biopharma Limited · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a double-blind, randomised, parallel group study, where a total of 105 healthy adult male volunteers, ≥ 18 and ≤ 55 years of age, non-smoker, will be dosed; 35 subjects per treatment group, randomly assigned to one of the 3 treatment arms.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-08-19
• Completion: 2019-08-19
• First posted: 2018-12-14
• Last updated: 2024-11-19

Locations

1 site across 1 country: Australia