Abstract

After preclinical animal models and early safety testing, your investigational compound is ready for the First-in-Man (FIM) clinical safety trial in humans with the perspective of demonstrating proof-of-concept at an early stage using suitable surrogate markers depending on the mechanism of action.

When a compound showed potential for human therapeutic use, it is recommended to identify at an early stage a suitable dose range for further clinical testing, based not only on safety and tolerability data, but also on plasma exposure and, where possible, the outcome of early signals on pharmacodynamics.

Join us live to discuss the specific challenges associated with the design and conduct of your phase-I clinical study to demonstrate safety and tolerability with simultaneous measurements of plasma concentrations as a prerequisite for safely achieving proof-of-concept in healthy subjects or in the target patient population.

In this 45-minute webinar, Dr. Wolfgang Timmer, Senior medical advisor at NUVISAN will cover the following topics:

• Dose considerations for first-in-man studies and risk aspects
• Design elements single-ascending dose & multiple-ascending dose studies
• Search for pharmacodynamic endpoints and surrogates
• Early proof-of-concept studies
• Live Q&A session