What is the primary focus during the Phase I trial?

The primary focus during Phase I trials is to determine the optimal drug dosage for participants. Phase I trials are typically the first step in testing a new drug in humans and often involve a small group of healthy volunteers. The objective at this stage is to assess how the drug is metabolized and excreted, as well as to gather initial data on safety and tolerability. By establishing the appropriate dosage, researchers aim to identify the maximum tolerable dose without adverse effects, which is essential for the design of later-phase trials.

Other aspects such as assessing drug efficacy and performing long-term toxicity studies are not the main goals of Phase I trials. Instead, those considerations become more relevant in later phases of drug development, where the focus shifts to evaluating how effective the drug is against the condition it targets and understanding the long-term implications of its use.