In August 2021, we initiated our first-in-human trial for PBI-0451. This trial is anticipated to enroll up to 180 healthy volunteers. The Phase 1 study is a placebo-controlled, blinded, randomized, dose escalation study of PBI-0451 in healthy volunteers designed to evaluate the safety, tolerability, and pharmacokinetics of PBI-0451 after single and multiple ascending doses.
This study will also evaluate the drug-drug interaction potential of PBI-0451, including upon its coadministration with ritonavir.
PRDS is leaning toward a 1400mg daily dose of PBI-0451 (two 350mg tablets BID, taken with food), according to the company’s presentation at CROI this week: