Planning First-in-Human Clinical Trials

This guide outlines the essential steps for planning first-in-human (FIH) clinical trials, which are critical for evaluating new drugs in human subjects. It begins by detailing necessary regulatory interactions and emphasizes the importance of selecting an appropriate starting dose to balance safety and efficacy. The document describes trial design strategies, including single ascending dose (SAD) and multiple ascending dose (MAD) studies, highlighting the need for careful monitoring of participant safety and pharmacokinetics. The role of a Safety Review Committee (SRC) is discussed, including its responsibilities in overseeing trial safety and making dose escalation recommendations. Additionally, the guide stresses the importance of a well-documented Safety Monitoring Plan (SMP) to ensure that safety data is effectively collected and reviewed throughout the trial process. By following these guidelines, sponsors can mitigate risks and enhance the likelihood of successful trial outcomes.