Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Swissmedic, the Swiss regulatory agency for therapeutic products, has granted an approval to MonoSol and Midatech to initiate Phase I clinical trial of gold nanoparticle/insulin incorporated into PharmFilm drug delivery technology in Switzerland.
Subscribe to our email newsletter
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.