UPDATE : Monday, September 7, 2020
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Regulator OKs P2 trial of Covid-19 plasma therapy
  • By Lee Han-soo
  • Published 2020.08.20 14:55
  • Updated 2020.08.20 14:55
  • comments 0

GC said that the Ministry of Food and Drug Safety has approved the phase 2 clinical trial of GC5131A, the company’s new plasma treatment for Covid-19.

GC has won an IND approval to conduct phase 2 clinical trials for GC5131A from the Ministry of Food and Drug Safety. (GC)

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 purpose of this trial is to establish an appropriate dose of the drug and explore its safety and effectiveness,” the company said. “This is the first time that the ministry has been approved for phase 2 clinical trials among the COVID-19 treatments under development other than drug re-indication research.”

GC will 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.

“As the production of the clinical trial formulation has already been completed, patient administration will begin soon,” the company said.

GC’s Medical Director Kim Jin said, “The voluntary participation of the people is the driving force behind the development of plasma therapy.

The company asks for more interest and participation in the development of the therapy, Kim added.


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