What types of patients are included in a Phase I clinical trial for drug development?

In a Phase I clinical trial, the primary focus is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug. By conducting these trials with a small group of healthy participants who do not have the disease condition, researchers can closely monitor how the drug affects individuals in a controlled environment, minimizing any confounding health variables associated with the disease.

This phase is crucial because it sets the safety parameters for dosage and potential side effects. The data collected from these healthy individuals help inform the next stages of clinical trial development, which will subsequently test the drug on actual patients with the specific disease condition in later phases. The inclusion of healthy participants helps ensure that the effects observed are due to the drug itself rather than other health complications associated with a particular condition.