A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
This Phase 2 study is a two-stage, serial cohort dose escalation and expansion study of a
single 30-minute (IV) infusion of HBI-3000 for the conversion of patients with recent-onset
atrial fibrillation (AF).
Stage A is open label and all patients will receive HBI-3000. In each of three dose cohorts,
up to 10 patients will receive HBI-3000 by IV infusion (30 minutes). Three different dose
levels are planned to be administered serially, lowest to highest, with assessment of safety,
tolerability, and efficacy prior to proceeding to the next dose level group.
Following Stage A, the iDMC will recommend up to two doses of HBI-3000 to be further explored
in Stage B. Stage B is a serial, randomized, double-blind and placebo-controlled cohort of
two different doses of HBI-3000, with a dose decision after the first cohort. Stage B will be
powered to show a difference between HBI-3000 and placebo in conversion rate at each of the
two dose levels.