ACTRN12622001351707招募中1 期
Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Safety, Tolerability, and Pharmacokinetic Study of MAX-001 in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Able to understand, sign, and commit to informed consent and to all study procedures
- •- Adhere to effective double-barrier contraception or in proven post-menopause
- •- Healthy as determined during screening based on medical history, physical examination, vital signs, ECG (QTcF <=450 msec in males, QTcF <=470 in females), and laboratory assessments
- •- Body Mass Index 18 to 32.0 kg/m2
- •- Non-smokers or light smokers (less than 10 cigarettes per week)
- •- Commitment to adhere to lifestyle guidance during the study participation
排除标准
- •- Any lifetime antecedent, any disease or medication indicative of past seizures, including childhood febrile seizures, epilepsy, or any disease or medication that increases the risk of seizures or any family history of seizures or epilepsy
- •- Any antecedent of ischemic heart or cerebrovascular disease, angina, prior history of a myocardial infarction, stroke, transient ischemic attack (TIA), cervical artery dissection, QTcF > 450 msec in males and > 470 msec in females, QRS prolongation, arrhythmia, and prior occurrence of torsades de pointe as well as absence of family history of long QT syndrome or sudden cardiac death
- •- Any antidepressant use, such as a monoamine oxidase inhibitor like phenelzine, a tricyclic antidepressant such as amitriptyline or nortryptiline, or a single-, double-, or triple monoamine reuptake inhibitor (SSRI, SNRI, NDRI, NRI, SNDRI)
- •- Use of drowsiness-causing antihistamines, anticholinergics, sympathomimetics (including decongestant nasal sprays containing ephedrine), or antidepressants
- •- Serology indicative of HIV or hepatitis B or C
- •- Abnormal liver function tests
- •- Abnormal renal function tests as assessed by the creatinine clearance
- •- Past or current cancer and its treatment
- •- Glaucoma
- •- Substance use disorder in medical history, urine drug screen and alcohol breath test
- •- Mental health disorder diagnosis and/or treatment
- •- Pregnancy or breastfeeding
研究者
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