GC said that it has applied for an investigational new drug (IND) application to conduct phase 2 clinical trials for Covid-19 plasma therapy, GC5131A, to the Ministry of Food and Drug Safety.
|GC has submitted an IND application to conduct phase 2 clinical trials for GC5131A to the Ministry of Food and Drug Safety. (GC)|
The purpose of this trial is to establish an appropriate dose of the drug and to explore its safety and effectiveness, the company said.
GC plans to conduct the trial on 60 subjects at five local hospitals -- Samsung Medical Center, Asan Medical Center, Chung-ang University Hospital, Korea University Ansan Hospital, and Chungnam National University Hospital.
GC5131A is a hyperimmune globulin produced by extracting various effective immune antibodies from the plasma of patients in the recovery phase of Covid-19. As hospitals have regularly used hyperimmune globulin to treat patients, the company expects it to simplify the development process.
“The production of clinical trial preparations has been completed. The first patient administration will be performed as soon as possible after the IND is approved,” the company said in a press release.
GC medical head Kim Jin said, “We will do our best to put GC5131A into the medical field as soon as possible.”
The company expects that GC5131A will be able to secure a platform for the treatment of new infectious diseases that may occur in the future in addition to Covid-19, Kim added.
<© Korea Biomedical Review, All rights reserved.>