Phase I trials usually enroll which participants?

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Phase I trials are mainly about safety, tolerability, and how the drug behaves in the body. To study these factors without interference from a disease, researchers typically enroll healthy volunteers who do not have the condition the drug targets. This setup helps establish a safe starting dose, determine the maximum tolerated dose, and characterize pharmacokinetics. In some cases—such as when the drug has significant toxicity or is intended for seriously ill patients—early testing may involve patients with the target disease, but the standard approach is healthy individuals. Animals are used in preclinical work before any human testing, and pharmacists are professionals, not trial participants.