What characterizes Phase 1 clinical trials?

Phase 1 clinical trials are primarily characterized by the administration of the investigational drug to healthy volunteers. The main objective during this phase is to evaluate the safety of the drug, determine its pharmacokinetics and pharmacodynamics, and identify any side effects. This stage lays the groundwork for understanding how the drug behaves in the human body, which is crucial before moving on to further testing in patients with the disease.

Testing on patients with the disease typically occurs in later phases of clinical trials, specifically Phase 2 and Phase 3, where the effectiveness of the drug is evaluated alongside safety. Additionally, assessing the drug's marketing potential is not a function of Phase 1 trials; that consideration comes later in the drug development process when efficacy and safety data are more robust, especially in Phase 3 trials when larger patient populations are involved and pivotal data for regulatory approval is collected. Thus, the correct response reflects the fundamental aims of Phase 1 trials, focusing on the initial safety evaluations with healthy participants.