We conduct single ascending dose (SAD) and multiple ascending dose (MAD) studies to characterize safety, tolerability, and dose–exposure relationships. Dose escalation decisions are supported by real-time safety and PK data review. Our unit enables flexible cohort scheduling and adaptive designs, allowing efficient progression through dose levels. These studies support optimal dose selection for later-phase trials and provide essential insight into accumulation and steady-state behavior.
Ethics Committee approval for all studies
Medical supervision by experienced clinical staff
Clear participant information and informed consent
Conducted in compliance with ICH-GCP and EU regulations
