Phase II trials target which population?

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Phase II trials are designed to test whether the treatment has a real therapeutic effect in people who actually have the disease being studied. After initial safety and dosing are explored in Phase I, usually with healthy volunteers (though sometimes patients are included in early oncology Phase I), Phase II focuses on efficacy and further safety specifically in the target patient population with the disease. This helps determine if the intervention works under real disease conditions and informs dosing refinements. It wouldn’t be conducted in healthy volunteers because the goal here is to see disease-specific benefit, not initial safety in individuals without the condition; it isn’t aimed at the general population without the disease; and it isn’t done in animals because animal studies precede human trials.