Clinical Trial, Phase I

**Definition:** Work that is the report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques based on a small number of healthy persons and conducted over the period of about a year in either the United States or a foreign country.

**Tree numbers:** - V03.175.250.100

**Synonyms:** - Clinical Trial, Phase 1