Synonym: first-in-man (FIM).
First study of a novel intervention in humans.
First-in-human studies are usually carried out in healthy volunteers. Their principal role is to assess the safety of new interventions. They may incorporate a dose-escalation study design (single ascending dose or SAD study) to identify the optimum dose for use in future trials. First-in-human studies are also used to gather data on the effects of a new drug in humans and how it is metabolized. First-in-human studies are phase 1 trials.
Revised guideline on first-in-human clinical trials (EMA, 2017)
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (FDA, 2005)
Design and Conduct Considerations for First‐in‐Human Trials (Clinical and Translational Science, 2019)
REVIVE webinar: ‘Clinical development of antimicrobials – Phase 1 development challenges’ by Markus Zeitlinger (GARDP, 2020)