Celltrion’s COVID-19 antibody therapy candidate CT-P59 was given the approval to carry out clinical phase 1 trial in the UK, the company said Thursday.
A clinical phase 1 trial is conducted on a small group of relatively healthy people, to test the drug candidate’s preliminary indications in human body, including its effectiveness, toxicity and any possible side effects.
Celltrion said it is now recruiting eligible people for the trial.
After this trial will follow Clinical phase 2 and 3 trials, which target patients more severely afflicted with the COVID-19.
These advanced trials are anticipated to take place around the end of the year. A phase 4 clinical trial for the follow-up study of the drug’s long-term effects will finalize in the first quarter of 2021, according to Celltrion.
Celltrion will begin preemptively manufacturing the commercial batch for CT-P59 from September. For this, the company has begun readjusting next year’s manufacturing assignments at its plant in Songdo, Incheon.
Domestically, Celltrion has begun a phase 1 clinical trial on the drug targeting 32 healthy people through Chungnam University Hospital since July 17. Celltrion said it expects to have the results from this trial within the third quarter.
By Lim Jeong-yeo (email@example.com