Phase I Double Blind Safety, Tolerability and PK Evaluation of a COVID-19 Therapy in Healthy Volunteers
Our clients, Daewoong Pharmaceutical and Mankind Pharma, needed help with the expeditious and efficient conduct of a Phase I Generic drug trial to evaluate the safety and tolerability of the anti-parasitic drug Niclosamide in the treatment of COVID-19. The drug, delivered as an intramuscular depot, was found to be efficacious against SARSCoV-2 in pre-clinical studies. As this is a novel route of administration, the company needed to apply for a New Drug Application and were seeking an end-to-end clinical trials partner.
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