GC Green Cross Applies for Phase 2 Clinical Trial of COVID-19 Plasma Therapy

The Fastest Development Speed Among Domestic COVID-19 Treatments

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] GC Green Cross announced on the 29th that it has submitted an Investigational New Drug (IND) application for the Phase 2 clinical trial protocol of its COVID-19 plasma treatment ‘GC5131A’ to the Ministry of Food and Drug Safety.

The purpose of this clinical trial is to determine the appropriate dosage of the drug and to explore its safety and efficacy.

The trial will be conducted on 60 subjects across five hospitals: Samsung Seoul Hospital, Seoul Asan Hospital, Chung-Ang University Hospital, Korea University Ansan Hospital, and Chungnam National University Hospital.

GC5131A is a hyperimmunoglobulin made by extracting various effective immune antibodies from the plasma (the liquid component of blood) of patients recovering from COVID-19.

Since hyperimmunoglobulin has been used in the human body for a long time, the development process can be simplified. Accordingly, except for drug repurposing products, GC5131A will enter Phase 2 clinical trials the fastest.

GC Green Cross has currently completed the production of the clinical trial drug. Once the IND is approved, the first patient administration will proceed as quickly as possible.

Jin Kim, Head of Medical Affairs at GC Green Cross, said, “We will do our best to deploy GC5131A to medical sites within a short period.” He added, “Through GC5131A, we expect to secure a treatment platform for new infectious diseases that may occur in the future, beyond COVID-19.”

This content was produced with the assistance of AI translation services.