Overview

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

Status:
Completed

Trial end date:
2019-08-19

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Prestige Biopharma Limited
Prestige Biopharma Ltd
Prestige Biopharma Pte Ltd

Treatments:

Trastuzumab