Definition

A study that determines the best dose of a new drug or treatment. In a dose-escalation study, the dose of the test drug is increased a little at a time in different groups of people until the highest dose that does not cause harmful side effects is found. A dose-escalation study may also measure ways that the drug is used by the body and is often done as part of a phase I clinical trial. These trials usually include a small number of patients and may include healthy volunteers.