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

NCT04680026 · tracked via the Priya Life Science USA tracker

Sponsor

HUYABIO International, LLC.

Phase

Phase 2

Started

2021-06-01

Last updated

2025-12-02

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

HBI-3000Placebo

HBI-3000: Small molecule, multi-ion channel blocker

Placebo: Normal saline

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * 18 to 80 years of age * Sustained AF of \> 2 hours and \< 72 hours duration * Eligible for cardioversion (electrical and pharmacologic) * On adequate anticoagulant therapy or eligible for anticoagulation during treatment and for at least 30 days duration after treatment if indicated by ACC/AHA/HRS or country specific national or international guidelines for thromboembolic risk reduction related to AF Exclusion Criteria: * Atrial fibrillation \< 2 hours or \> 72 hours duration or with duration not reliably established at the time of dosing * Hemodynamic instability that may require emergency electrical cardioversion * Atrial flutter * Moderate to severe HF * Clinical or ECG signs of acute cardiac ischemia or digitalis toxicity * Known or suspected hyperthyroidism * Cardiac surgery, stroke, TIA, acute MI/ PCI, unstable angina, or persistent angina at rest within the previous 3 months * Presence of LA thrombus by TEE or TTE * Presence of concurrent myocarditis or endocarditis * ECG abnormalities: Current QTcF \> 480 msec; QRS interval \> 120 msec and/or a complete bundle branch block (BBB)l Delta wave or other pre-excitation pattern consistent with WPW syndrome; Acute coronary ischemia patterns * Use of medication that prolongs the QTc interval or history of: Long QT syndrome, congenital or acquired; Torsades de Pointes (TdP); Brugada Syndrome; Ventricular arrhythmia (not including infrequent isolated PVC) * Concurrent treatment with Class I or III antiarrhythmic drugs, metformin or strong CYP2D6 inhibitors (unless the medication is discontinued \> 5 half-lives before enrollment) * Treatment with oral amiodarone in the previous 3 months or IV amiodarone administered within 24 hours prior to planned Study Drug administration * Use of vernakalant, or any experimental drug within 30 days or five half-lives (whichever is longer) of Study Drug administration, or use of an invasive investigational medical device within 2 months prior to Study Drug administration, or current enrollment in another study with investigational agent or procedure * Clinically significant laboratory abnormalities

Primary outcome measure(s)

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by the incidence of adverse events (AEs) — 30 days
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by the incidence of adverse events (AEs)
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in heart rate (HR) — 90 minutes
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in heart rate (HR) from baseline (prior to Study Drug infusion) to study timepoints during and after Study Drug infusion, specifically: HR \< 40 bpm for 2 minutes or longer within 90 minutes of initiation of the infusion HR increase \> 25 percent before conversion to SR (based on one minute averages compared between the event and the first minute of stable telemetry) HR \> 120 bpm for one minute or longer after conversion to SR and within 90 minutes of initiation of the infusion
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in blood pressure (BP) — 90 minutes
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in blood pressure (BP) from baseline (prior to Study Drug infusion) to study timepoints during and after Study Drug infusion, specifically: Systolic BP \< 90 mmHg for \> 1 minute during SR and within 90 minutes of initiation of the infusion
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes above a specific level — 24 hours
Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes from baseline (prior to Study Drug infusion) to 24 hour post-infusion, specifically: QTcF: \> 500 msec and \> 60 msec above the 24-hour post-conversion level during SR PR: \> 50 percent above the 24-hour post-conversion level during SR QRS: ≥ 33 percent above the 24-hour post-conversion level during SR
The efficacy of intravenously (IV) administered HBI-3000 as measured by the proportion of patients with AF of recent onset who convert to SR — 120 minutes
Evaluate the efficacy of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset as measured by the proportion of patients with AF of recent onset who convert to SR (for a duration of at least one minute) within 120 minutes of the start of infusion

Trial sites (14)

Facility	City	Region
NCH Research Institute	Naples	Florida
Prairie Education & Research	Springfield	Illinois
North Mississippi Medical Center	Tupelo	Mississippi
CHRISTUS Trinity Mother Frances Hospital - Tyler	Tyler	Texas
University Clinical Center of the Republic of Srpska	Banja Luka	Bosnia and Herzegovina
Montreal Heart Institute	Montreal	Quebec
Centre hospitalier de L'Universite de Montral (CHUM)	Montreal	Quebec
Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le Gardeur	Terrebonne	Quebec
Waikato Hospital	Hamilton	New Zealand
Wellington Regional Hospital	Wellington	New Zealand
Niš University Clinical Center	Niš	Bulevar Doktora
University Clinical Center of Serbia	Belgrade	Serbia
Dedinje Institute for Cardiovascular Diseases	Belgrade	Serbia
University Hospital Medical Center Bezanijska kosa	Belgrade	Serbia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04680026 on ClinicalTrials.gov ↗ ← All trials in the USA