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