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 whitepaper, we discuss:
- Determining the needed regulatory interactions
- Selecting the starting dose
- Designing the trial
- Ensuring the safety of study participants
- Identifying and preventing potential operational risks
- Recruiting and retaining study participants
- Resourcing and trial conduct
Learn more about what to consider when planning your First-in-Human trials.