Single Ascending Dose (SAD) studies are early-phase trials where participants receive a single dose of an investigational product, with dose levels increasing across cohorts.
SAD designs are used to evaluate initial safety, tolerability, and pharmacokinetics while minimizing exposure duration and controlling risk. These studies often include sentinel dosing, intensive monitoring, and predefined stopping rules to protect participants at higher dose levels. SAD data inform dose selection for subsequent multiple-dose studies and help characterize exposure-response relationships early in development. Well-executed SAD trials provide foundational evidence for safe progression in clinical development.