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

Phase 1 Completed 105 enrolled Prestige Biopharma Limited

RandomizedParallel-groupTriple-blindScreening

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.

Timeline

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

Publications

Demarchi M, Coliat P, Mclendon K, Chung Shii Hii J, Feyaerts P, Ang F, Jaison L, Deforce F, Derde MP, Kim MJ, Park LS, Detappe A, Pivot X. TROIKA-1: A double-blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU-Herceptin(R) and US-Herceptin(R) in healthy male subjects. Pharmacol Res Perspect. 2021 Aug;9(4):e00839. doi: 10.1002/prp2.839.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HD201	Unknown	6 mg/kg	Intravenous
Comparator	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous

Indications

No indication recorded.