Title: phase I clinical studies
Long Title: IUPAC Gold Book - phase I clinical studies
DOI: 10.1351/goldbook.12708
Status: current

Definition
Initial introduction of an investigational new drug into humans.

Note
These studies are designed to determine the metabolic and pharmacologic actions of the drug in humans, the side-effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

Related Terms
- investigational new drug: https://goldbook.iupac.org//terms/view/12673
- phase II: https://goldbook.iupac.org//terms/view/12709
- phase III: https://goldbook.iupac.org//terms/view/12710
- phase IV: https://goldbook.iupac.org//terms/view/12711

Source
- PAC, 2013, 85, 1725. 'Glossary of terms used in medicinal chemistry. Part II (IUPAC Recommendations 2013)' on page 1746 (https://doi.org/10.1351/PAC-REC-12-11-23)

Other Outputs
- html: https://goldbook.iupac.org/terms/view/12708/html
- json: https://goldbook.iupac.org/terms/view/12708/json
- xml: https://goldbook.iupac.org/terms/view/12708/xml

Citation: Citation: 'phase I clinical studies' in IUPAC Compendium of Chemical Terminology, 5th ed. International Union of Pure and Applied Chemistry; 2025. Online version 5.0.0, 2025. 10.1351/goldbook.12708
License: The IUPAC Gold Book is licensed under Creative Commons Attribution-ShareAlike CC BY-SA 4.0 International (https://creativecommons.org/licenses/by-sa/4.0/) for individual terms.
Collection: If you are interested in licensing the Gold Book for commercial use, please contact the IUPAC Executive Director at executivedirector@iupac.org .
Disclaimer: The International Union of Pure and Applied Chemistry (IUPAC) is continuously reviewing and, where needed, updating terms in the Compendium of Chemical Terminology (the IUPAC Gold Book). Users of these terms are encouraged to include the version of a term with its use and to check regularly for updates to term definitions that you are using.
Accessed: 2026-08-04T21:11:44+00:00