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ACTIVE NOT RECRUITING
NCT04680026
PHASE2

A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)

Sponsor: HUYABIO International, LLC.

View on ClinicalTrials.gov

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

Interventions

DRUG

HBI-3000

Small molecule, multi-ion channel blocker

DRUG

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