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

Last updated: January 7, 2025
Sponsor: HUYABIO International, LLC.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Chest Pain

Dysrhythmia

Arrhythmia

Treatment

HBI-3000

Placebo

Clinical Study ID

NCT04680026
HBI-3000-402
  • Ages 18-80
  • All Genders

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 Criteria

Inclusion

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 treatmentand for at least 30 days duration after treatment if indicated by ACC/AHA/HRS orcountry specific national or international guidelines for thromboembolic riskreduction related to AF

Exclusion

Exclusion Criteria:

  • Atrial fibrillation < 2 hours or > 72 hours duration or with duration not reliablyestablished 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 anginaat 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 acomplete bundle branch block (BBB)l Delta wave or other pre-excitation patternconsistent 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; Ventriculararrhythmia (not including infrequent isolated PVC)

  • Concurrent treatment with Class I or III antiarrhythmic drugs, metformin or strongCYP2D6 inhibitors (unless the medication is discontinued > 5 half-lives beforeenrollment)

  • Treatment with oral amiodarone in the previous 3 months or IV amiodaroneadministered 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 invasiveinvestigational 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

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: HBI-3000
Phase: 2
Study Start date:
June 01, 2021
Estimated Completion Date:
June 30, 2025

Study Description

This is a two-stage study in patients with AF of recent onset:

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). For each dosing cohort, sentinel dosing is planned. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment. In Stage A, 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. The actual dose levels may be modified, and additional dose levels may be considered based on the observed results at each cohort.

Stage B is the randomized, double-blind and placebo-controlled part of the study. Study drug for Stage B patients is either HBI-3000 or placebo. Two cohorts will be enrolled sequentially, lowest dose level first, with safety, efficacy, and available PK results evaluated by the Sponsor and iDMC prior to enrolling patients in the next/higher dose cohort. The dose level for the second cohort may be adjusted following interim review of results in the first cohort. Patients will be randomized to receive a single IV infusion of HBI 3000 or placebo over 30 minutes. In each of the dose cohorts, sequentially enrolled patients will be randomized at 2:1 ratio so that 40 patients will receive HBI 3000 infusion and 20 patients will receive placebo infusion. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment.

Connect with a study center

  • Gold Coast University Hospital

    Southport, Queensland 4215
    Australia

    Site Not Available

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000
    Bosnia and Herzegovina

    Site Not Available

  • Cardiology Department, PHI Hospital Sveti Vracevi

    Bijeljina, 76300
    Bosnia and Herzegovina

    Site Not Available

  • University Clinical Center Tuzla

    Tuzla, 75000
    Bosnia and Herzegovina

    Site Not Available

  • Centre hospitalier de L'Universite de Montral (CHUM)

    Montréal, Quebec H2X 0C1
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montréal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le Gardeur

    Terrebonne, Quebec J6V 2H2
    Canada

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju, 61707
    Korea, Republic of

    Site Not Available

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton, 3240
    New Zealand

    Site Not Available

  • Wellington Regional Hospital

    Wellington, 6021
    New Zealand

    Site Not Available

  • Niš University Clinical Center

    Niš, Bulevar Doktora 18108
    Serbia

    Site Not Available

  • Clinical Hospital Center Zvezdara

    Belgrade, 11120
    Serbia

    Site Not Available

  • Dedinje Institute for Cardiovascular Diseases

    Belgrade, 11040
    Serbia

    Site Not Available

  • University Clinical Center of Serbia

    Belgrade, 11000
    Serbia

    Site Not Available

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080
    Serbia

    Site Not Available

  • Health Center Uzice

    Užice, 31000
    Serbia

    Site Not Available

  • Grandview Medical Group Research

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • HonorHealth Research Institute and Innovation

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • NCH Research Institute

    Naples, Florida 34102
    United States

    Site Not Available

  • Research Physicians Network Alliance/Florida Cardiology

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Prairie Education & Research

    Springfield, Illinois 62701
    United States

    Site Not Available

  • St. Vincent Heart Center

    Carmel, Indiana 46260
    United States

    Site Not Available

  • Lutheran Hospital

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • UofL Health - UofL Physicians, Cardiology Associates

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • North Mississippi Medical Center

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • AMG Heart and Vascular Center

    Bartlesville, Oklahoma 74006
    United States

    Site Not Available

  • Ascension St. John Clinical Research Institute

    Tulsa, Oklahoma 74101
    United States

    Site Not Available

  • CHRISTUS Trinity Mother Frances Hospital - Tyler

    Tyler, Texas 75701
    United States

    Site Not Available

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