Follicum has obtained approval from the BfArM (the Federal Institute for Drugs and Medical Devices in Germany) and the research ethics committee to start a clinical Phase I/II a study. The study will now proceed according to the previously communicated plan.
The study will be performed by the Clinical Research Center for Hair and Skin Science (CRC) in Berlin, Germany. Both the safety profile of the candidate drug FOL-005 and various efficacy parameters will be studied to support identification of the optimum dose.
Treatment of around 30 healthy volunteers is planned and the study is scheduled to be finalized during 2016.