A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Etripamil in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cmax of Etripamil after single dosing
研究概览
简要总结
The objectives of the study are as below:
Primary:
·To evaluate the pharmacokinetics (PK) of Etripamil in healthy adult Chinese subjects
Secondary:
- To evaluate the pharmacodynamics (PD) of Etripamil in healthy adult Chinese subjects
- To evaluate the safety and tolerability of Etripamil in healthy adult Chinese subjects
Exploratory:
·To evaluate the PK exposure-PD response relationship of etripamil in healthy adult Chinese subjects
详细描述
This is a randomized, double-blind, placebo-controlled phase 1 study in healthy adult Chinese subjects to evaluate the PK, PD, safety and tolerability of single dose of etripamil, 70 mg nasal spray (NS). After signing the informed consent form (ICF), potential subjects will undergo screening procedures within 28 days prior to dosing. Eligible subjects will be admitted to the clinical unit on Day -1 and screening procedures will be repeated to confirm eligibility. Subjects will fast overnight for at least 10 hours prior to dosing. 12 healthy adult Chinese subjects will be randomized to receive etripamil 70 mg single dose (n=10) or placebo (n=2).
Blood and urine samples will be collected for PK assessments of etripamil and the inactive main metabolite MSP-2030.
AEs, 12-lead ECGs, clinical laboratory tests, vital signs, physical examinations, and concomitant medications will be collected and evaluated over the course of study.
Subjects will remain in clinic until discharged on Day 2. There will be a follow-up telephone call on Day 11 (±1 day) of dosing. Total duration for each subject will be approximately 1.5 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
JX02001 is a double blind phase 1 study.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who meet all the following criteria at screening may be included in the study:
- •Ethnically Chinese men or women, 18 to 45 years of age (inclusive).
- •Body weight: male ≥50 kg, female ≥45 kg; body mass index (BMI) within 18 to 26 kg/m2 (inclusive).
- •Healthy subject as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital signs.
- •Able to comprehend and willing to sign the ICF which includes compliance with the inclusion and exclusion criteria listed in the ICF and in the protocol.
- •Non-smoker or ex-smoker for >6 months.
- •From the time they sign the informed consent to 90 days (male subject within 30 days) after dosing, subjects have no plans to have children and voluntarily use effective contraception
排除标准
- •Any of the following will exclude subjects from the study:
- •Have a history of, or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal disease; thyroid disease; neurologic or psychiatric disease; or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
- •A history of atrioventricular (AV) block, (1st, 2nd or 3rd degree), myocardial infarction (MI) or angina, non-sustained or sustained ventricular tachycardia (VT), torsade de pointes, family history of sudden death or prolonged QT interval, vaso-vagal syncope, sick sinus syndrome, supraventricular tachycardia, atrial flutter, atrial fibrillation (AFib), stroke, transient ischemic attack (TIA), unexplained syncope, congestive heart failure (CHF).
- •Acute upper respiratory tract infection within 14 days prior to dosing.
- •Any abnormality of the nasal passage.
- •Unable to tolerate IN administration.
- •Known sensitivity to verapamil or other drugs or foods.
- •Clinically significant abnormal values for clinical laboratory tests at screening as deemed appropriate by the investigator.
- •Serum potassium <3.5mmol/L or serum magnesium <0.75mmol/L or serum calcium <2.11mmol/L.
- •Systolic blood pressure (SBP) <100 or >140 mmHg, diastolic blood pressure (DBP) <55 or >90 mmHg, HR <65 or >95 bpm.
- •QTcF >440 msec, flat or biphasic T waves, QRS >105 ms, evidence of a prior MI, pathologic U waves or U waves that interfere with the QT measurement, AV block or left anterior hemiblock (LAHB) or left posterior hemiblock (LPHB) or right bundle branch block (RBBB) or left bundle branch block (LBBB), pre-excitation syndrome.
- •Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening as deemed appropriate by the Investigator.
- •Have a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; have a history of treponema pallidum antibody positive, or tests positive for treponema pallidum; have a history of hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCVAb) positive, or other clinically active liver disease, or tested positive for HBsAg or HCVAb at screening.
- •History of drug or alcohol abuse in the last 2 years..
- •Positive test result(s) for alcohol and/or drugs of abuse at screening or admission (Day-1).
- •Received an investigational drug or used an invasive investigational medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before dosing.
- •Use of any prescription or non-prescription medication within 14 days or 5 half-lives (whichever is longer), or complementary and alternative medicine within 28 days before dosing (excluding aspirin, ibuprofen, and acetaminophen).
- •Any blood donation within 60 days prior to dosing, or any plasma donation within 30 days prior to dosing, or receipt of blood products within 60 days prior to dosing.
- •Vaccinated within 30 days prior to dosing or planned to be vaccinated during this study.
- •Have preplanned surgery or procedures that will interfere with the conduct of the study.
- •Sponsor staff and/or staff at the study site.
研究组 & 干预措施
Etripamil Nasal Spray 70mg
Etripamil Nasal Spray 70mg single dose
干预措施: Etripamil Nasal Spray 70mg (Drug)
Etripamil Placebo Nasal Spray 70mg
Etripamil Placebo Nasal Spray 70mg single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Cmax of Etripamil after single dosing
时间窗: Day -1 to Day 11
To measure Cmax of Etripamil after single dosing
Cmax of MSP-2030 after single dosing
时间窗: Day -1 to Day 11
To measure Cmax of MSP-2030 after single dosing
次要结局
- PR interval after single dosing(Day -1 to Day 11)
- Blood pressure after single dosing(Day -1 to Day 11)
- Heart rate after single dosing(Day -1 to Day 11)
- Subject incidence of Adverse Event (AE)(Day -1 to Day 11)
- Subject electrocardiogram outcomes(Day -1 to Day 11)
- Subject clinical laboratory tests outcomes(Day -1 to Day 11)
- Concomitant medications that subjects take(Day -1 to Day 11)