Schwabe, Christian
Wynne, Chris
Dyapa, Dayaker Reddy
Prajapati, Arpitkumar
Dadke, Disha
Clinical trials referenced in this document:
Documents that mention this clinical trial
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of BP02 (Trastuzumab Biosimilar) Compared to EU- and US-Approved Trastuzumab in Healthy Adult Male Volunteers: A Phase 1, Randomized, Double-Blind Study
https://doi.org/10.1007/s40487-024-00289-0
Article History
Received: 6 May 2024
Accepted: 25 June 2024
First Online: 7 July 2024
Declarations
:
: Christian Schwabe and Chris Wynne are employees and shareholders in NZCR. Dayaker Reddy Dyapa, Arpitkumar Prajapati, and Disha Dadke are employees of CuraTeQ Biologics Pvt Ltd.
: The study was approved by the Health and Disability Ethics Committee (HDEC; approval number 20/STH/190) and was registered at the Australian New Zealand Clinical Trials Registry (ANZCTR) prior to the initiation of subject screening (ACTRN12621000573853). The study was conducted in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (ICH guideline E6-R2), followed all ethical principles originating in the Declaration of Helsinki, and adhered to all relevant local ethical regulations. Subjects were required to give informed consent prior to study enrollment, and it was ensured that the privacy rights of the enrolled participants were always observed.