The purposes of a Phase I clinical trial (study) of a new treatment include evaluating how the new treatment should be given safely to people. Phase I trials involve administration of a new treatment to either healthy volunteers or patients with the same type of disease.
If the new treatment is a drug, a Phase I trial attempts to answer how should the drug be given (by mouth, injected into the blood, or injected into the muscle), how often should the drug be given, and what dose of the drug is safe. A Phase I clinical trial usually enrolls only a small number of patients, sometimes as few as a dozen patients.
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