Last updated on July 2019

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


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