ACTRN12624000223538尚未招募1 期
A Phase 1 Study of FlecIH-103 (Flecainide Acetate Inhalation Solution) Administered Using an Investigational, Single Use, Vibrating Mesh Nebulizer Delivery System to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1.Be male or female, 18 to 70 years of age (inclusive), at the time of screening;
- •2.Agree to use protocol specified method(s) of contraception. Acceptable Methods of Contraception During Study Participation, if a male participant or a female participant of childbearing potential who engages in heterosexual intercourse.
- •For the purposes of this study, a female born subject 18 years or older is considered of childbearing potential until becoming post-menopausal, unless permanently sterile or with medically documented ovarian failure. Women are considered to be in a postmenopausal state when they have cessation of previously occurring menses for at least 12 months without an alternative cause. Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral salpingectomy in a female subject of any age;
- •3.Agree to refrain from egg or sperm donation for the duration of the study;
- •4.Be able and willing to sign the informed consent for (ICF) as approved by the Human Research Ethics Committee (HREC). Written consent must be provided before initiating any screening evaluations. Participants must have read and understood the ICF, must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments;
- •5.Have a body mass index (BMI) greater than or equal to 18.0 and less than or equal to 35.0 kg/m2 and a body weight greater than or equal to 60 kg and less than or equal to 120 kg;
- •6.Have no significant medical history, condition, and be in good general health as determined by the Principal Investigator (PI) or delegate at the clinical facility;
- •7.Have no electrocardiographic abnormalities during a 12-lead ECG conducted at screening and/or pre-dose assessment (measured after the participant is semi-recumbent for at least 5 minutes) that, in the opinion of the PI (or delegate), may compromise the participant’s safety in the study. Final study eligibility for the ECG criteria is to be approved by the PI and/or the SC;
- •8.Have no clinically significant abnormalities (i.e., structural heart disease) or left ventricular (LV) dysfunction detected on standard diagnostic or hand-held echocardiogram in the opinion of the Investigator;
- •9..Be willing and able to comply with all study assessments and adhere to the protocol schedule;
- •10.Have suitable venous access for blood sampling and/or injection of medication if needed;
- •11.Have alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values less than 1.5 times the upper limit of normal (ULN) and Cockcroft-Gault estimated creatinine clearance greater than 70 mL/min at screening;
- •13.Have electrolytes within the normal range (specifically potassium greater than or equal to 3.8 mEq/L) at screening;
- •14.Have no abnormal finding of clinical significance at screening;
- •15.Meets the following specific cardiovascular (measured with a 12-lead ECG) and hemodynamic parameters:
- •-Heart Rate (HR) greater than or equal to 47 bpm
- •-PR Interval less than or equal to 190 ms
- •-QRS intervalless than or equal to 105 ms
- •-QTcF duration less than or equal to 450 ms for males
- •less than or equal to 470 ms for females
- •-Systolic BP greater than or equal to 100 to less than or equal to 140 mmHg
- •-Diastolic BP greater than or equal to 60 to less than or equal to 100 mmHg
- •16.Meets the following specific pulmonary assessments related to pulmonary function testing;
- •-FEV1 (forced expiratory volume in 1 second) – report the
排除标准
- •1.Evidence of asthma, chronic obstructive pulmonary disease (COPD) or major pulmonary airway disease. This exclusion criterion also applies to individuals with established pulmonary disease in need of inhalation medication. However, individuals with history of childhood asthma but no subsequent episodes are eligible to participate in this study;
- •2.Evidence of early repolarization pattern in the ECG, defined as elevated J-Point or end-QRS slurring with or without concave ST-segment elevation [MacFarlane, 2015]. A J-Point elevation of greater than or equal to 0.1 mV and prominent end-QRS notch or slur in 2 contiguous ECG leads should be flagged for review by the study cardiologist and/or medical monitor. Minor findings are considered acceptable;
- •3.Has a history of heart disease, including but not limited to, atherosclerotic cardiovascular disease (ASCVD), myocardial infarction (MI), heart failure of any cause, clinically significant cardiac arrhythmias and valvular heart disease;
- •4.Has existing cardiac issues secondary to a prior invasive cardiac procedure;
- •5.Clinically significant family history of cardiac arrhythmias, acquired or congenital (e.g., Brugada and/or long-QT syndromes), unexplained sudden cardiac death, and/or unexplained syncope;
- •6.Family history of congenital airway lung obstructive disease;
- •7.Use of prescription medication or over-the-counter products (including other antiarrhythmic drugs, anticoagulants and blood pressure lowering drugs, medications known to prolong the QTc interval, natural food supplements, vitamins, and garlic as a supplement) within 7 days prior to administration of study treatment, except for topical products without systemic absorption, paracetamol, and/or protocol-compliant contraceptives;
- •8.Any contraindications to flecainide as per Tambocor package insert;
- •9.Has experienced any symptomatic heart failure (per New York Heart Association [NYHA] guidelines), or history of impaired LVEF;
- •10.Has human immunodeficiency virus (HIV) infection, as shown by the presence of anti HIV antibody (i.e., sero-positive);
- •11.Is sero-positive for hepatitis B or hepatitis C virus, and/or has a history of delta virus hepatitis;
- •12.Any of the following related to COVID-19:
- •a.Known ongoing COVID-19 infection;
- •b.Significant pulmonary sequelae that limit the participant’s ability to inhale medication or secondary cardiomyopathy from a previous COVID-19 infection, in the opinion of the Investigator.
- •13.Has uncontrolled hypertension: BP greater than 150/100 mmHg;
- •14.Has a history of torsades de pointes, atrial and/or ventricular rhythm disturbances (e.g., atrial or ventricular tachycardia or fibrillation), sinus bradycardia (less than 47 bpm), Cardiac Conduction Disease (AV Nodal Block or PR interval greater than 190 ms), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG;
- •15.Has had episodes of syncope, including during blood draw;
- •16.Currently abuses and/or has a history of alcohol and/or drug abuse less than 12 months from screening;
- •17.Regularly uses excessive alcohol within six months prior to the screening visit (i.e., more than fourteen units of alcohol per week [1 Unit of 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]);
- •18.Has a positive standard 10x panel drug test at screening and/or has a history of drug abuse within 12 months from screening;
- •19.Are currently participating in and have not participated in any other investig
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