Phase I trial
In Trial design & structure
Also known as: phase 1, first-in-human
A Phase I trial is usually the first time a treatment is given to people. It focuses on safety, tolerability, and how the body absorbs and clears the drug, and typically involves a small number of participants — often tens rather than hundreds. Depending on the treatment, participants may be healthy volunteers or patients with the target condition.
Example
A first-in-human study gives single ascending doses to small groups of healthy volunteers, with intensive monitoring and blood sampling, and only moves to the next dose after a safety review.
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