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New IV drug aims to jolt atrial fibrillation back to normal rhythm in minutes

NCT ID NCT04680026

Disease control Sponsor: HUYABIO International, LLC. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a single 30-minute IV infusion of HBI 3000 in 150 adults with atrial fibrillation that started within the last 3 days. The goal is to safely convert the heart back to normal rhythm. The trial first finds the best dose, then compares it to a placebo in a blinded fashion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

Contacts and locations

Locations

  • CHRISTUS Trinity Mother Frances Hospital - Tyler

    Tyler, Texas, 75701, United States

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

    Montreal, Quebec, H2X 0C1, Canada

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

    Terrebonne, Quebec, J6V 2H2, Canada

  • Dedinje Institute for Cardiovascular Diseases

    Belgrade, 11040, Serbia

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8, Canada

  • NCH Research Institute

    Naples, Florida, 34102, United States

  • Niš University Clinical Center

    Niš, Bulevar Doktora, 18108, Serbia

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Prairie Education & Research

    Springfield, Illinois, 62701, United States

  • University Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000, Bosnia and Herzegovina

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080, Serbia

  • Waikato Hospital

    Hamilton, 3240, New Zealand

  • Wellington Regional Hospital

    Wellington, 6021, New Zealand

More trials for these conditions

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