Multiple Ascending Dose (MAD) describes an early-phase study design in which participants receive repeated doses of an investigational product, with dose levels increased in sequential cohorts.
MAD studies are used to evaluate safety, tolerability, pharmacokinetics, and sometimes pharmacodynamics under conditions that better reflect intended clinical use than single-dose studies. Cohort escalation decisions rely on predefined safety criteria, dose-limiting toxicity rules, and monitoring plans. MAD designs often generate key information for selecting dose regimen, frequency, and exposure targets for later-phase trials. Because risk may increase with repeat exposure, MAD protocols typically include intensive monitoring and clear stopping rules to protect participants.