[Infostock Daily=Reporter Park Jeong-Do] Celltrion will begin Phase 1 clinical trials to administer CT-P59, a Covid-19 treatment, to mild patients following healthy people.
Celltrion announced on the 26th that it will start full-scale recruitment of patients after receiving approval of the Phase I clinical trial plan (IND) for mild patients of CT-P59, an antibody treatment, from the Korea Food and Drug Administration on the 25th.
This phase 1 focuses on evaluating the safety, tolerability and viral neutralization of CT-P59 in patients with Corona 19 mild patients. It will be conducted in cooperation with a number of medical institutions such as Incheon Medical Center, Gachon University Gil Hospital, and Inha University Hospital.
Celltrion completed Phase I clinical trials to evaluate safety by administering CT-P59 to healthy people at Chungnam National University Hospital last month.
Global clinical trials have been approved by the UK Medicines Healthcare Products Regulatory Authority (MHRA) at the end of July and are in the process of receiving Phase 1 for mild patients. Based on the same clinical design, the first phase of the clinical trial will be completed early.
Celltrion plans to conduct Phase 2-3 clinical trials for mild patients and Phase 3 clinical trials for prevention and moderate clinical trials to secure interim results for these clinical trials by the end of this year.
In the case of preventive clinical trials, patients with confirmed contacts and asymptomatic confirmed patients will be selected as subjects to prevent infection and to confirm the effective death effect of the early virus.
Celltrion will begin full-scale commercial production more than 10 times from September to enable mass supply as soon as it obtains approval for use of CT-P59.
Reporter Park Jeong-Do newface0301@naver.com
