First-in-Human trials represent a critical milestone in medical device and drug development. These studies mark the first time an investigational product is tested in humans, focusing primarily on safety, feasibility, and early performance data. Proper study design is essential to minimize risk while generating meaningful clinical insights.

Key First-in-Human study designs include:

• Single Ascending Dose (SAD): Gradually increases exposure levels in small participant groups to assess initial safety and tolerability.

• Multiple Ascending Dose (MAD): Evaluates safety and performance over repeated use or exposure.

• Feasibility Studies: Early assessments to confirm device functionality and usability in a real clinical setting.

• Pilot Studies: Small-scale trials designed to refine protocols and endpoints before larger studies.

• Dose-Escalation Designs: Carefully structured approaches to determine optimal dosing or device parameters.

• Adaptive Designs: Allow protocol modifications based on interim safety and performance data.

• Early Safety and Performance Studies: Focus on real-time monitoring to detect risks quickly and protect participants.

FIH trials require strong regulatory oversight, ethical review, and experienced clinical teams. Thoughtful planning, conservative risk management, and clear stopping rules are essential to ensure participant safety while accelerating innovation. When executed correctly, First-in-Human studies lay the foundation for successful clinical development and future regulatory approval.