Pardes Biosciences, Inc., a clinical-stage biopharmaceutical company developing PBI-0451 as a potential novel direct-acting, oral antiviral drug candidate for the treatment and prevention of SARS-CoV-2 infections and associated diseases (i.e., COVID-19), announced that its Investigational New Drug ( IND ) application for PBI-0451 has been cleared by the U.S. FDA .
PB-0451 is currently being evaluated in a Phase 1 placebo -controlled, blinded, randomized, dose escalation study in healthy volunteers in New Zealand evaluating the safety, tolerability, and pharmacokinetics of PBI-0451 after single and multiple ascending doses. Pardes anticipates reporting data from this ongoing study at a scientific conference later this quarter.
