NL-OMON20666暂停不适用
A Phase 1a Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX-002 in Healthy Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 96
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female = 18 to = 55 years of age at the time of the Screening Visit.
- •2. In good health based on medical history, physical examination (including neurological examination), vital sign measurements, and laboratory safety tests obtained at Screening.
- •3. No clinically significant abnormality on the single ECG performed at Screening and the triplicate ECG performed prior to the first administration of study drug. Single ECG performed at Screening may be repeated once.
排除标准
- •1. Estimated creatinine clearance of = 90 mL/min based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey 2009).
- •2. History or evidence of any of the following: myocardial infarction; cardiac valvulopathy; cardiac surgery revascularization (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty); unstable angina; cerebrovascular accident, stroke, or transient ischemic attack; pacemaker; atrial fibrillation, flutter, or nonsustained or sustained VT; pulmonary arterial hypertension; sick sinus syndrome, second- or third-degree atrioventricular (AV) block; uncontrolled hypertension; congestive heart failure; personal or family history of sudden death or long QT syndrome; unexplained syncope or syncope within the last 3 years regardless of etiology; or history of hypokalemia.
- •3. Screening Holter monitor (24 hours) shows nonsustained VT, SVT lasting > 10 beats in a run or > 4 runs, atrial fibrillation, atrial flutter, or a pause > 4 seconds.
- •4. Mean pulse < 50 or > 100 bpm, mean systolic blood pressure >140 mm Hg, or mean diastolic blood pressure > 90 mm Hg at Screening measured in triplicate using a calibrated digital device. If the mean blood pressure
- •exceeds the limits above, an additional set of blood pressure measurements will be obtained, and the subject may be included if pulse and BP parameters are within the permitted boundaries.
- •5. Troponin T out of the normal laboratory range at time of the Screening Visit.
- •6. Consumption of excessive amounts of caffeine, defined as > 4 servings of coffee, tea, cola, or other caffeinated beverages per day (1 serving is approximately 120 mg of caffeine). Refusal to abstain from caffeine-containing foods or caffeinated beverages (eg, coffee, tea, cola, energy drinks) 5 days prior to Day -1 through discharge from the CRU after the final administration of study drug.
- •7. Refusal to abstain from grapefruit-containing foods or beverages or Seville orange-containing foods or beverages 14 days prior to Day -1 through the Follow-Up Visit
- •8. Refusal to abstain from consumption of cruciferous vegetables (eg, kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard greens) or charbroiled meats (meat grilled over any heat source with black
- •marks) = 7 days prior to Day -1 through the Follow-Up Visit
- •9. Abnormal thyroid function tests (thyroid-stimulating hormone [TSH], triiodothyronine, free thyroxine [FT4]) out of the normal laboratory value ranges at the time of the Screening Visit.
- •10. Aspartate aminotransferase, alanine aminotransferase, or gamma-glutamyl transferase > 1.5 times the upper limit of normal at the time of the Screening Visit and at Day -1.
研究者
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