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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Evaluate the proportion of patients with sustained AF or late conversion to SR
Evaluate the time to conversion to SR from start of infusion
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HBI-3000
2021
Completed Phase 1
~90
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
HUYA Bioscience InternationalLead Sponsor
8 Previous Clinical Trials
738 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
47 Patients Enrolled for Atrial Fibrillation
HUYABIO International, LLC.Lead Sponsor
11 Previous Clinical Trials
829 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
47 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I haven't had any major heart issues or strokes in the last 3 months.I have moderate to severe heart failure.My heart's electrical activity is not normal based on my recent ECG.I am not currently taking certain heart rhythm medications, metformin, or strong drugs that affect liver enzyme CYP2D6.I have not taken oral amiodarone in the last 3 months or IV amiodarone in the last 24 hours.I haven't used any experimental drugs or devices recently.My atrial fibrillation lasts less than 2 hours or more than 72 hours, or its duration is unknown.I may need an emergency procedure to correct my heart's rhythm.I have been diagnosed with atrial flutter.I am between 18 and 80 years old.I do not have inflammation of the heart muscles or lining.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.You have symptoms or signs of a recent heart attack or problems with your heart's electrical activity.You have important irregularities in your lab test results.
Research Study Groups:
This trial has the following groups:- Group 1: Drug: HBI-3000, Stage B Dose Level 2
- Group 2: Drug: HBI-3000, Stage A Dose Level 1
- Group 3: Drug: HBI-3000, Stage A Dose Level 2
- Group 4: Drug: HBI-3000, Stage A Dose Level 3
- Group 5: Drug: HBI-3000, Stage B Dose Level 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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