What is typically assessed during a Phase I clinical trial?

During a Phase I clinical trial, the primary focus is on assessing the safety and tolerability of the drug in healthy volunteers or, in some cases, in individuals with the condition the drug is intended to treat. This phase is crucial for determining how the drug behaves in the body, including its pharmacokinetics (how the body absorbs, distributes, metabolizes, and excretes the drug) and the appropriate dosage range. Researchers monitor participants closely to identify any adverse effects or reactions and to determine the highest dose that can be administered safely.

While the other aspects such as market value, disease effectiveness, and long-term side effects are important in the overall drug development process, they are typically addressed in later phases of clinical trials. Phase II trials begin to evaluate effectiveness against a specific disease, and Phase III trials provide more extensive data on long-term side effects and overall efficacy. Therefore, the correct focus of Phase I trials remains on safety and tolerability.