FIH
Medical abbreviation · Medical Research
| Stands for | First-in-human |
|---|---|
| Categories | Medical |
FIH stands for First-in-human, a medical research abbreviation.
First administration of a new drug, biologic or device to people, typically in a small phase 1 study of healthy volunteers or patients that focuses on safety, tolerability, pharmacokinetics and doses for further study. Starting doses are derived from animal data with wide safety margins.
Example: FIH study: single ascending doses in eight cohorts of healthy volunteers.
Usage notes
The 2006 TGN1412 trial in London, in which six volunteers developed life-threatening cytokine storms within hours of dosing, led to stricter guidance on starting doses and staggered dosing. Oncology FIH trials usually enroll patients rather than healthy volunteers because of expected toxicity. Older writing says first-in-man.
Related abbreviations
More medical research abbreviations
- DSMB – Data and safety monitoring board
- EBM – Evidence-based medicine
- EDC – Electronic data capture
- EMA – European Medicines Agency
- EUA – Emergency use authorization
- FAERS – FDA Adverse Event Reporting System
- FWA – Federalwide Assurance
- GCP – Good Clinical Practice
- GLP – Good Laboratory Practice
- GRADE – Grading of Recommendations Assessment, Development and Evaluation
- HR – Hazard ratio
- HRQoL – Health-related quality of life
See all 94 medical research abbreviations →
This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.