The single, ascending dose, double blind trial, enrolling 27 healthy male volunteers, is designed to evaluate the safety profile of gold nanoparticle bound insulin when administered transbuccally to healthy volunteers.
MonoSol Rx president and CEO Mark Schobel said this trial represents a major advancement in the treatment of diabetes and for the millions of patients worldwide who have been waiting for an easy-to-administer oral insulin formulation that eliminates the need for injection.
The companies concluded that the Phase 1 study will be performed in a clinical research unit near Basel, Switzerland and results will be released during Q1 2012.