Phase I trial
Definition: Phase I in a clinical trial is the first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection), and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of treatments being tested, phase I trials usually include only a small number of patients, who have not been helped by other treatments. (CNet) These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A Phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
For more information: See clinical trials, Phase II trial
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Definitions are provided for education only and are not medical advice. Created exclusively for Phoenix5. © 2002 Phoenix5.
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