HBI-3000 for Atrial Fibrillation

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: HUYA Bioscience International

No Placebo Group

Prior Safety Data

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.

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.

+1 more

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.

+12 more

Participant Groups

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.

5Treatment groups

Experimental Treatment

Group I: Drug: HBI-3000, Stage B Dose Level 2Experimental Treatment2 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 1Experimental Treatment2 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 3Experimental Treatment1 Intervention

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

Group IV: Drug: HBI-3000, Stage A Dose Level 2Experimental Treatment1 Intervention

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

Group V: Drug: HBI-3000, Stage A Dose Level 1Experimental Treatment1 Intervention

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