Definitions for "Phase I trial"
Keywords:  dosage, dose, mtd, volunteers, healthy
Initial testing in a small group of humans to determine safety, dosing and identify side effects associated with an investigational drug.
Clinical trial conducted to find the safest dose and most effective way to give a new cancer treatment to patients, as well as identify potential side effects. Phase I trials are usually limited to a small number of patients who would not be helped by other known treatments.
A clinical trial to study the pharmacology of an investigational medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial.