HBI-3000 for Atrial Fibrillation

Recruiting at 25 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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Eligibility Criteria

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

I am between 18 and 80 years old.

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.

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

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

Treatment Details

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.

Participant Groups

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+