Phase I clinical trials are the first stage in the drug development process, and they involve testing the safety and tolerability of a new drug in a small group of healthy volunteers or patients. The primary objective of Phase I trials is to determine the drug's safety profile, including its maximum tolerated dose and any potential adverse effects. These trials also help to establish the drug's pharmacokinetics and pharmacodynamics, which are essential for determining dosing and scheduling in later stages of drug development. Phase I trials typically involve a small number of participants and can last several months to a year, depending on the drug's complexity and safety profile.
