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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-001021-74
    Sponsor's Protocol Code Number:HBI-3000-402
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-03-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-001021-74
    A.3Full title of the trial
    A Phase 2, Two-Stage, Serial Cohort Dose Escalation and Expansion Study of a Single Intravenous Infusion of HBI-3000 for the Conversion of Atrial Fibrillation (AF) of Recent Onset
    Dwuetapowe, seryjne, kohortowe badanie fazy II dotyczące zwiększania i rozszerzania dawki pojedynczego wlewu dożylnego HBI-3000 w celu konwersji migotania przedsionków (AF) o niedawnym początku
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess how Safe and Effective HBI-3000 is for the Conversion of Atrial Fibrillation (AF) of Recent Onset
    A.3.2Name or abbreviated title of the trial where available
    HBI-3000-402
    A.4.1Sponsor's protocol code numberHBI-3000-402
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04680026
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHUYABIO International, LLC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHUYABIO International, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHUYABIO International, LLC
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street Address12531 High Bluff Drive, Suite 138
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post code92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18587988800
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHBI-3000 (Sulcardine Sulfate)
    D.3.2Product code HBI-3000
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.1CAS number 343935-61-5
    D.3.9.2Current sponsor codeHBI-3000
    D.3.9.3Other descriptive nameSulcardine sulfate
    D.3.9.4EV Substance CodeSUB267693
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number325
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sustained atrial fibrillation (AF) of over 2 hours and <72 hours duration up to the time of dosing, eligible for cardioversion (electrical and pharmacologic)
    E.1.1.1Medical condition in easily understood language
    Sustained atrial fibrillation (AF)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    • 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
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female adult patients (“adult" in accordance with age requirements per local regulations) with sustained AF of > 2 hours and < 72 hours duration at the time of dosing. Enrollment of patients over 85 years of age should be done with caution at the discretion of the Investigator.
    2. Eligible for cardioversion (electrical and pharmacologic)
    3. Females of childbearing potential (premenopausal female capable of becoming pregnant; FOCBP) must use an effective method of contraception for at least 1 month before enrollment in the study as assessed by the Investigator. In addition, FOCBP must agree to use adequate birth control measures during the study and for 30 days after the dose of Study Drug. Acceptable methods of birth control in this trial include: (i) two highly effective methods of birth control as determined by the Investigator and local regulations regarding the use of birth control methods for patients participating in clinical trials (one of the methods must be a barrier technique); (ii) male partner sterilization (sterile male should be the sole partner for that patient), or (iii) true abstention from sexual intercourse (when in line with the usual lifestyle of the patient)
    4. Post-menopausal females, aged over 45 years who have not had a period for at least 12 months and are not using hormonal contraception, or females documented as permanently sterile (e.g., bilateral tubal ligation; hysterectomy, bilateral salpingectomy)
    5. Negative serum pregnancy test at inclusion (FOCBP only)
    6. A woman must agree not to donate eggs (ova; oocytes) for purposes of reproduction for at least 30 days after receiving Study Drug infusion.
    7. All men (due to potential risk of drug exposure through the ejaculate) who are sexually active must agree to a highly effective method of birth control during the study and for 30 days after the dose of Study Drug (90 days for male patients in Canada). All men must
    also agree not to donate sperm for at least 30 days (90 days for male patients in Canada) after receiving Study Drug infusion.
    8. On adequate anticoagulant therapy or eligible for anticoagulation during treatment and for at least 30 days duration after treatment if indicated by the current applicable guidelines of the ACC/AHA/HRS, the Canadian Cardiovascular Society (CCS), the European Society of Cardiology (ESC), or other relevant country-specific national or international guidelines for thromboembolic risk reduction related to AF.
    9. Capable of completing Screening and study procedures as described in the protocol
    10. Capable of providing written informed consent
    E.4Principal exclusion criteria
    1. Atrial fibrillation < 2 hours or > 72 hours duration or with duration not reliably established at the time of dosing.
    2. Patients with hemodynamic instability as defined by systolic BP < 90 mmHg that may require emergency cardioversion
    3. Left ventricular ejection fraction (LVEF) < 40% in SR in the previous 6 months or severely reduced ejection fraction (EF), i.e., < 35% in presence of AF
    4. The presence of New York Heart Association (NYHA) Class III or IV symptoms of HF with any of the following:
    a. Plasma B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) serum level > 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 (< 50 bpm) at Screening
    13. History of sick sinus syndrome without implanted pacemaker
    14. History of second-degree Type II or any third-degree AV block without implanted pacemaker
    15. Concurrent treatment with Class I or III antiarrhythmic drugs or metformin (unless the medication is discontinued > 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 < 3.5 mmol/L
    b. Serum potassium > 5.5 mmol/L
    c. Serum magnesium < 0.7 mmol/L
    d. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or total bilirubin > 2× upper limit of normal
    e. Creatinine clearance of < 30 mL/minute or serum creatinine > 1.8 mg/dL as estimated by Cockcroft-Gault formula (Section 18.4)
    f. TSH < 0.4 mIU/L
    g. Digoxin level > 1.5 ng/mL
    h. Positive serum pregnancy test (FOCBP only)
    i. Hemoglobin < 10 g/dL
    26. Female patients who are pregnant or are planning to become pregnant within the next 30 days or currently breastfeeding
    27. Male patients planning to donate sperm within 30 days (90 days for male patients in Canada)
    28. Receiving experimental treatment with agent(s) not yet on the market, within 30 days or within 5 half-lives of the agent(s), whichever is longer
    29. Presence of concurrent myocarditis or endocarditis
    30. Any other existing medical condition that in the opinion of the Investigator, excludes study participation
    31. Previously exposed to HBI-3000
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A duration of 120 minutes beginning at the start of the 30 minute infusion.
    E.5.2Secondary 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
    E.5.2.1Timepoint(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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Stage A is open label and Stage B is double blind.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Korea, Republic of
    New Zealand
    United States
    Bosnia and Herzegovina
    Serbia
    Poland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of Study is defined as completion of the final Follow-Up phone call for the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days23
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will continue under their own physician's care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-16
    P. End of Trial
    P.End of Trial StatusOngoing
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