Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
Sponsor: HUYABIO International, LLC.
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.
Official title: A Phase 2, Two-Stage, Serial Cohort Dose Escalation and Expansion Study of a Single Intravenous Infusion of HBI 3000 for the Conversion of Atrial Fibrillation (AF) of Recent Onset
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2021-06-01
Completion Date
2025-12-31
Last Updated
2025-12-02
Healthy Volunteers
No
Conditions
Interventions
HBI-3000
Small molecule, multi-ion channel blocker
Placebo
Normal saline
Locations (14)
NCH Research Institute
Naples, Florida, United States
Prairie Education & Research
Springfield, Illinois, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
CHRISTUS Trinity Mother Frances Hospital - Tyler
Tyler, Texas, United States
University Clinical Center of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina
Montreal Heart Institute
Montreal, Quebec, Canada
Centre hospitalier de L'Universite de Montral (CHUM)
Montreal, Quebec, Canada
Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le Gardeur
Terrebonne, Quebec, Canada
Waikato Hospital
Hamilton, New Zealand
Wellington Regional Hospital
Wellington, New Zealand
Niš University Clinical Center
Niš, Bulevar Doktora, Serbia
University Clinical Center of Serbia
Belgrade, Serbia
Dedinje Institute for Cardiovascular Diseases
Belgrade, Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade, Serbia