Successful conclusion of the first Phase I study with C21
Vicore Pharma reports the conclusion of the clinical conduct of its first Phase I trial with C21. The study was conducted on male healthy volunteers at Clinical Research Services Turku – CRST Oy in Finland under the guidance of Mika Scheinin, Professor of Pharmacology at the University of Turku. The single ascending dose study comprised six dose levels of C21 to evaluate safety and tolerability and to evaluate pharmacokinetic properties of the drug. There were no serious adverse reactions reported in the study and C21 appeared safe in doses ranging from 0,3 to 100 mg.
”We are happy to assist Vicore Pharma with this first-in-man study and we are pleased that the study has passed uneventfully. We now look forward to evaluate also multiple ascending dosing for this exciting new drug”, Professor Scheinin says in a statement.
”To us and all of our research partners who have dedicated much effort and resources on C21, this is an important milestone that brings us confidence as we advance C21 towards patients with idiopathic pulmonary fibrosis”, says Per Jansson, Managing Director of Vicore Pharma.
As a next step, a multiple ascending dose study on healthy male volunteers will be initiated. Results from this study are due during Q4 2016. Alongside the collaboration with CRST, also SP Process Development, located at Södertälje, Sweden, has assisted Vicore Pharma with the development and manufacturing of the trial product.
”The selection of strategic collaboration partners is highly critical for us as a small company and we are very pleased with the high degree of quality and professionalism of both CRST and SP Process Development”, says Lena Lindblad, Ph.D., project leader at Vicore Pharma.
For further information, please contact:
Per Jansson, CEO
Tel: +46 (0) 709-17 47 46 or e-mail: email@example.com
Lena Lindblad, Project Leader
Tel: +46 (0) 706-03 46 25 or e-mail: firstname.lastname@example.org