Tackling Challenges in First-In-Human Trials

The purpose of First-In-Human (FIH) trials is to study the human pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), tolerability, and safety of an investigational medicinal product (IMP) having already gone through preclinical studies, and to evaluate how the effects translate from animals to humans. They allow sponsors to determine potential risks associated to the drug at each step of its development and determine the safe dose range in the course of its clinical progression.

In this issue of The Altascientist, we discuss:

• Advantages of working with one CRO from preclinical to clinical
• Key aspects in designing a successful FIH trial
• The importance of having quick access to special and patient populations
• How adaptive trial designs in FIH studies can save drug developers significant time and millions in program costs
• Case study: Adaptive, FIH trial to assess safety, tolerability, PK, and food effect of single and multiple ascending doses (SAD/MAD) of a novel small molecule