A first-in-human (FIH) clinical trial is a significant milestone in the development of a potential new drug. A successfully conducted FIH trial provides a solid foundation of knowledge regarding the safety and exposure of an IP, at several dose levels, within a relatively short period of time. The data generated can help identify opportunities to accelerate or enhance a compound's clinical development in the future. This document is intended to serve as a broad checklist for success in your FIH clinical trials.
