Trials will begin in mid-June, 2008 followed by the completion of necessary investigations for an investigational new drug application (IND) filing as required by the PMDA (Pharmaceutical and Medical Devices Agency). The purpose of this clinical study is to assess the safety, efficacy and appropriate dose for the IND product in healthy adults aged 20-40.
Shuichi Kanazashi, president and CEO of UMN Pharma, said: “In response to the concerns about an increasing threat of pandemic influenza virus, we are developing UMN-0501 which will enable production of larger quantities of vaccine in a shorter period of time, and we will do our best to continue with the smooth implementation of clinical trials in order to provide a steady supply of UMN-0501 as soon as possible.”