HBI-3000 for Atrial Fibrillation

Phase 2

Waitlist Available

Research Sponsored by HUYA Bioscience International

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 hours, 24 hours and 7 days

Summary

This trial is a two-stage study of HBI-3000, a drug used to convert patients with recent-onset atrial fibrillation. In stage A, patients will receive the drug in escalating doses to assess safety and efficacy. In stage B, the most effective dose will be determined in a placebo-controlled setting.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions related to heart rhythm changes (like palpitations), issues from IV infusion (such as infection at the site), and any general medication-related side effects which will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 hours, 24 hours and 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 hours, 24 hours and 7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hours, 24 hours and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes above a specific level

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in blood pressure (BP)

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in heart rate (HR)

+2 more

Secondary study objectives

Evaluate the proportion of patients with sustained AF or late conversion to SR

Evaluate the time to conversion to SR from start of infusion