After the previous webinar regarding the content of an Investigator’s Brochure (IB), the current webinar is the logical next step in which we focus on how to use this document to de-risk a First-in-Human (FIH) trial. To that end, the use of a Risk Assessment Categorization Tool (RACT) will be explained in order to move safely from animals into humans. Subsequently, the principles to adhere to in calculating the starting dose for a FIH trial are discussed and illustrated.

Speakers: Dr. Thomas Lodeweyckx and Prof. Dr. Jan de Hoon (UZ Leuven)

This is the second of two webinars. First webinar was on June 3, 2022 - IB for an Early Phase/FIH trial: more than just a regulatory document