Last updated on August 2020

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

Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03776240

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.