Sustained atrial fibrillation (AF) of over 2 hours and <72 hours duration up to the time of dosing, eligible for cardioversion (electrical and pharmacologic) MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: HBI-3000 (Sulcardine Sulfate)
Product Code: HBI-3000
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Not applicable
CAS Number: 343935-61-5
Current Sponsor cod
Sponsors
HUYABIO International, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adult patients (“adult" in accordance with age requirements per local regulations) with sustained AF of > 2 hours and =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Atrial fibrillation 72 hours duration or with duration not reliably established at the time of dosing. 2. Patients with hemodynamic instability as defined by systolic BP 2 to 3 times the upper limit of normal b. Any indication of HF on chest radiography performed at the discretion of the Investigator 5. Use of medication that prolongs the QTc interval (http://crediblemeds.org) and which in the opinion of the Investigator represent a clinical risk when combined with the Study Drug 6. Cardiac surgery within the previous 3 months or percutaneous implanted cardiac device Note: However, permanent pacemaker and previous ablation procedures are permitted based on the discretion of the Investigator. 7. Stroke or transient ischemic attack (TIA) within the previous 3 months 8. Atrial flutter documented on 12-lead ECG at the time of enrollment 9. Presence of left atrial (LA) thrombus by TEE or TTE 10. ECG abnormalities: a. Current QTc > 480 msec b. QRS interval > 120 msec and/or a complete bundle branch block (BBB) c. Delta wave or other pre-excitation pattern consistent with Wolff-Parkinson-White (WPW) syndrome 11. History of: a. Long QT syndrome, congenital or acquired b. TdP c. Brugada Syndrome d. Sustained VT 12. Sustained bradycardia ( 5 half-lives before enrollment) 16. Treatment with oral amiodarone in the previous 3 months or IV amiodarone administered within 24 hours prior to planned Study Drug administration 17. Use of vernakalant or any experimental drug within 30 days or 5 half-lives (whichever is longer) of Study Drug administration, use of an invasive investigational medical device within 2 months prior to Study Drug administration, or current enrollment in another study with investigational agent or procedure 18. Clinical or ECG signs of digitalis toxicity 19. Evidence of acute coronary syndrome as determined by the Investigator 20. Acute myocardial infarction (MI)/percutaneous coronary intervention (PCI), unstable angina, or persistent angina at rest within 3 months prior to Screening 21. History of moderate-to-severe aortic stenosis or hypertrophic cardiomyopathy with outflow tract obstruction 22. History of complex cyanotic congenital heart disease 23. Known or suspected hyperthyroidism based on clinical history of enlarged thyroid on physical exam or a previous low thyroid-stimulating hormone (TSH) laboratory value 24. Known drug or alcohol dependence within the past 12 months as judged by the Investigator 25. Clinically significant laboratory abnormalities: a. Serum potassium 5.5 mmol/L c. Serum magnesium 2× upper limit of normal e. Creatinine clearan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety and efficacy of IV-administered HBI-3000 in patients with AF of recent onset and determine the optimal tolerated and effective dose level for pharmacological cardioversion of AF of recent onset to SR. AF of recent onset is defined as an episode of AF ongoing at the time of dosing with a duration of 2 to 72 hours, as reported by the patient (to the best of the patient’s knowledge) or clinically diagnosed by ECG. The episode may be the first-known event in a patient with new-onset AF, or it may be a recurrent event in patients with paroxysmal AF.;Secondary Objective: • Define ECG changes associated with plasma levels of IV-administered HBI-3000 • Evaluate the time to conversion to SR from the start of infusion • Evaluate the proportion of patients with sustained AF or late conversion to SR;Primary end point(s): Primary Efficacy Endpoint The primary efficacy endpoint is the proportion of patients with AF of recent onset who convert to SR (for a duration of at least 1 minute) within 120 minutes of the start of infusion. The optimal tolerated effective dose level is defined as the dose level that results in the highest cardioversion rate without observation of dose-limiting AEs.;Timepoint(s) of evaluation of this end point: A duration of 120 minutes beginning at the start of the 30 minute infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints The secondary efficacy endpoints are: • Time from the start of infusion to the time of conversion to SR for a duration of at least 1 minute • Proportion of patients with sustained or late conversion of AF of recent onset to SR at 12 hours, 24 hours, and 7 days after the start of infusion Safety Endpoints • The incidence of AEs through 30-day follow-up • Measurement of clinical laboratory parameters • HR and BP changes from baseline (prior to Study Drug infusion) to study time points during and after Study Drug infusion • ECG interval changes from baseline (prior to Study Drug infusion) to post-infusion time points • ECG interval changes from immediately after conversion to SR to the 24-hour time point (if still in SR) • Cardiac rhythm abnormalities by 12-lead Holter monitor, 12-lead ECG, and telemetry rhythm monitor;Timepoint(s) of evaluation of this end point: Secondary Efficacy Endpoints: Pre-dose, end of infusion at 12-hours, 24 hours, and 7 days. Safety Endpoints: through 30 days after the start of infusion. | — |
Countries
Australia, Bosnia and Herzegovina, Canada, Korea, Republic of, New Zealand, Poland, Serbia, United States
Contacts
Public ContactClinical Operations Department
HUYABIO International, LLC
Outcome results
None listed