FIH dose selection beyond MABEL: Optimizing phase 1 clinical trial starting dose whilst protecting patient safety

Key Points

• Optimized starting doses enhance patient safety in phase 1 clinical trials, allowing for better risk management.
• Dose selection methodology informed by both theoretical models and historical data promotes safer trial designs.
• The FIH approach integrates safety assessments to limit adverse effects during initial dosing in human subjects.
• Understanding MABEL and its limitations may enable more effective dose optimization for future investigations.