Cellivery Applies for Phase 1 Clinical Trial of COVID-19 Treatment in Poland
[Asia Economy Reporter Junho Hwang] Cellivery announced on the 7th that it applied for the clinical trial application (CTA) for the Phase 1 clinical trial of the COVID-19 immune treatment iCP-NI to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products on the 6th.
This clinical trial is conducted to evaluate the safety and pharmacokinetic characteristics of iCP-NI, confirm the maximum tolerated dose (MTD), and determine the recommended dose for Phase 2 clinical trials.
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The company stated, "The probability of the clinical trial drug receiving final approval as a pharmaceutical product is statistically known to be about 10%, and results that do not meet expectations may arise during the clinical trial and product approval process. Accordingly, there is also a possibility that the company may change or abandon its commercialization plans."
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