NL-OMON50699已完成不适用
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 - SAD & MAD of ABX-002 in HV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
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
- 年龄范围
- 18 至 64（—）
入选标准
- •2. Male or female * 18 to * 55 years of age at the time of the Screening Visit.
- •7. In good health based on medical history, physical examination (including
- •neurological examination), vital sign measurements, and laboratory safety tests
- •obtained at Screening.
- •8. 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
- •3. Estimated creatinine clearance of * 90 mL/min based on the Chronic Kidney
- •Disease Epidemiology Collaboration (CKD-EPI) equation (Levey 2009).
- •6. 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.
- •8. 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
- •9. 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 duplicate
- •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.
- •11. Troponin T out of the normal laboratory range at time of the Screening
- •18. 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) 24 hours
- •prior to Day -1 through discharge from the CRU after the final administration
- •of study drug.
- •19. 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
- •20. 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
- •25. 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.
- •26. 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.
- •30. Personal history of epilepsy or familial history of epilepsy in a primary
- •relative (eg, sibling, parent, child) as documented by medical records or by
- •the history provided to the Investigator by the subject. Individuals with a
- •personal history of febrile seizures or seizures related to medication,
- •intoxication, or withdrawal.
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