Michael Stackpoole

May 9, 2024 | bpspubs.onlinelibrary.wiley.com | Lauren Walker |Daryl Hodge |Richard J. Fitzgerald |Michael Stackpoole

1 INTRODUCTION Phase 1 clinical trials are the critical dose-determining step in the clinical trial pathway for new therapeutics. Mostly undertaken in healthy volunteers, the primary objective is to establish the safe dose that is most likely to be effective in the population with the disease. They can be divided into phase 1a, usually undertaken in healthy volunteers, and some may include phase 1b, to be undertaken in a small number of individuals with the disease of interest.