CDISC-Gloss – The initial introduction of an investigational new drug into humans. Phase 1 studies are closely monitored and are most often conducted in normal healthy volunteer subjects but in specific cases also in patients.
NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [after ICH E8; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL
TRIALS, CPMP/ICH/291/95 March 1998] See also phase.