EUCTR2022-001021-74-PL进行中（未招募）1 期
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 - HBI-3000-402
HUYABIO International, LLC0 个研究点目标入组 150 人开始时间: 2023年3月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •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
- •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 clearan
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