HBI-3000 for Atrial Fibrillation

Not currently recruiting at 27 trial locations

Overseen By Jerry Riebman, MD, FACS, FACC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: HUYA Bioscience International

Must not be taking: QTc prolonging, Class I/III antiarrhythmics

Disqualifiers: Atrial flutter, Severe HF, Ischemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an IV treatment called HBI-3000 to determine its effectiveness for people with recent-onset atrial fibrillation (AF), a condition characterized by irregular heartbeats. Researchers aim to assess whether HBI-3000 can safely and effectively restore normal heart rhythm. The trial consists of two parts: first, testing different doses of the drug, and then comparing the most promising doses to a placebo (a harmless substance). Individuals who have experienced AF for more than 2 hours but less than 72 hours and are already on or can start blood thinners may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot be on Class I or III antiarrhythmic drugs, metformin, or strong CYP2D6 inhibitors unless they are stopped more than 5 half-lives before enrollment. Also, you should not have taken oral amiodarone in the past 3 months or IV amiodarone within 24 hours before the study drug is given.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that HBI-3000 is generally safe based on previous studies. In the 30 days following treatment, participants reported no serious side effects or heart rhythm issues related to the drug. The treatment only slightly affected average heart rate and blood pressure. Additionally, participants tolerated HBI-3000 well, with no issues serious enough to halt the study. These findings suggest that HBI-3000 is generally safe for individuals with a recent onset of atrial fibrillation, a type of irregular heartbeat. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for atrial fibrillation?

HBI-3000 is unique because it targets atrial fibrillation with a novel mechanism of action. While most treatments for atrial fibrillation, like beta-blockers and calcium channel blockers, focus on controlling heart rate or rhythm, HBI-3000 acts directly on cardiac ion channels to stabilize the heart's electrical activity. This could mean fewer side effects and potentially more effective management of atrial fibrillation. Researchers are excited about its potential to offer a new option for patients who don't respond well to existing therapies.

What evidence suggests that HBI-3000 might be an effective treatment for atrial fibrillation?

Research has shown that HBI-3000 may help treat atrial fibrillation (AF), a condition characterized by an irregular heartbeat. This trial will administer different dose levels of HBI-3000 to participants to assess its safety and effectiveness. In a study, patients taking HBI-3000 experienced no serious side effects, and it did not significantly alter their heart rate or blood pressure. Early results suggest that HBI-3000 can help restore a normal heart rhythm by affecting the heart's electrical signals, making it a promising new option for those seeking safer and more effective AF treatments. The evidence supports its potential to transform AF management. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with recent-onset atrial fibrillation lasting more than 2 hours but less than 72. Participants must be eligible for cardioversion and on or suitable for anticoagulant therapy. Exclusions include severe heart issues, certain past medical events like stroke, use of specific drugs, ECG abnormalities such as long QT syndrome, and those in other drug/device trials.

Inclusion Criteria

You have had a specific type of irregular heart rhythm for more than 2 hours and less than 72 hours.

I am a candidate for a procedure to correct my heart rhythm.

I am on or can start blood thinner treatment as per heart health guidelines.

Exclusion Criteria

I don't use medications that affect heart rhythm nor have a history of specific heart rhythm disorders.

A blood clot is found in the heart using a special heart imaging test.

I have or might have an overactive thyroid.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage A Treatment

Open label treatment with HBI-3000, administered in three dose cohorts with safety, tolerability, and efficacy assessments

Varies per cohort

1 visit (in-person) per cohort

Stage B Treatment

Randomized, double-blind, placebo-controlled treatment with HBI-3000 or placebo, administered in two dose cohorts

Varies per cohort

1 visit (in-person) per cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• IV HBI-3000

Trial Overview The study tests HBI-3000's ability to convert recent-onset atrial fibrillation to a normal rhythm via IV infusion. Stage A involves escalating doses in cohorts; all receive the drug. Stage B compares two selected doses against placebo in a randomized, double-blind setup to determine efficacy.

How Is the Trial Designed?

Group I: Drug: HBI-3000, Stage B Dose Level 2 Experimental Treatment 2 Interventions

Stage B Double-blind placebo controlled, Cohort 2 HBI-3000 Dose Level 2: Selected based on Stage A, and Stage B Cohort 1 results

Group II: Drug: HBI-3000, Stage B Dose Level 1 Experimental Treatment 2 Interventions

Stage B Double-blind placebo controlled, Cohort 1 HBI-3000 Dose Level 1: Selected based on Stage A results

Group III: Drug: HBI-3000, Stage A Dose Level 3 Experimental Treatment 1 Intervention

Stage A Open Label HBI-3000 Dose Level 2: 500 mg planned

Group IV: Drug: HBI-3000, Stage A Dose Level 2 Experimental Treatment 1 Intervention

Stage A Open Label HBI-3000 Dose Level 2: 350 mg planned

Group V: Drug: HBI-3000, Stage A Dose Level 1 Experimental Treatment 1 Intervention

Stage A Open Label HBI-3000 Dose Level 1: 200 mg

Who Is Running the Clinical Trial?

HUYA Bioscience International

Lead Sponsor

Trials

9

Recruited

870+

HUYABIO International, LLC.

Lead Sponsor

Trials

12

Recruited

960+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04680026

NCT04680026 | A Study of IV HBI-3000 for the Conversion ... 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 ...

2. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02126-5/fulltext

PO-07-195 SAFETY AND EFFICACY OF HBI-3000, AN ... No Serious Adverse Events or drug-related arrhythmias were seen through 30-day follow-up. HBI-3000 infusion had only minor impact on mean HR and BP, and an ...

3. huyabio.com huyabio.com/huyabio-presents-positive-clinical-results-from-hbi-3000/

HUYABIO Intl. Presents Positive Clinical Results from HBI ... HBI-3000 has strong potential to transform rhythm control treatment, meeting the urgent need for safer and more effective therapies for AF.” ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1547527125021265

PO-07-195 SAFETY AND EFFICACY OF HBI-3000, AN ... No Serious Adverse Events or drug-related arrhythmias were seen through 30-day follow-up. HBI-3000 infusion had only minor impact on mean HR and BP, and an ...

5. ahajournals.org ahajournals.org/doi/10.1161/circ.150.suppl_1.4136839

Abstract 4136839: HBI-3000: Pharmacological Conversion ... HBI-3000 IV produced a large linear reduction in JTpc contribution to the QT interval (Fig 1A, red). This is consistent with findings in SR (Fig ...

6. ahajournals.org ahajournals.org/doi/10.1161/circ.140.suppl_1.11495

Abstract 11495: HBI-3000: A Novel Drug for Conversion of ... Results: HBI-3000 was well tolerated with no dose limiting adverse events or arrhythmias observed. Table 1 summarizes ECG data at Cmax for each ...