NL-OMON51175已完成不适用
A Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ENX-101 at Plasma Steady State in Healthy Volunteers - MAD of ENX-101 in healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
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
- •Subjects must meet all the following criteria to be eligible for the study:
- •1. Healthy male and female volunteers aged 18 to 55 years, inclusive, at
- •2. Capable of giving written informed consent
- •3. Willing to give written consent to have data entered into *Verified Clinical
- •4. Female subjects
- •a. Of non-childbearing potential, defined as either permanently sterilized (at
- •least 4 months after surgical sterilization including bilateral salpingectomy,
- •tubal ligation, or oophorectomy with or without hysterectomy) or
- •post-menopausal (defined as amenorrhea for 12 consecutive months and documented
- •plasma follicle-stimulating hormone level >40 IU/mL; in the event a subject's
- •menopausal status has been clearly established and yet serum
- •follicle-stimulating hormone levels are not consistent with a post-menopausal
- •status, determination of the subject*s eligibility to be included in the study
- •will be at the Investigator*s discretion following consultation with the
- •Sponsor), and with a negative pregnancy test at Screening and Day *2; OR
- •b. Of childbearing potential and willing to use 2 effective methods of
- •contraception (i.e., established method of contraception + condom) or remain
- •abstinent (where abstaining from sexual intercourse is in line with the
- •preferred and usual lifestyle of the subject) from Day *2 through 3 months
- •after the last dose of study drug, and with a negative pregnancy test at
- •Screening and Day *2
- •5. Male subjects who, if fertile (defined as post-pubertal and not permanently
- •sterile by orchidectomy or vasectomy) must be willing to use a condom or remain
- •abstinent (where abstaining from sexual intercourse is in line with the
- •preferred and usual lifestyle of the subject) from Day *2 through 3 months
- •after the last dose of study drug
- •6. Body mass index of 18 to 35 kg/m2 at Screening
- •7. Willing and able to comply with all study requirements including the
- •a. Reside in the inpatient unit from Day *2 until discharge on Day 13
- •b. Refrain from strenuous exercise from Day *4 until Day 13
- •c. Abstain from grapefruit-, alcohol-, caffeine-, or xanthine-containing
- •products from Day *4 through Day 13
- •Part 2 Subjects Only
- •8. Subjects must have sleep pattern of going to bed between 10:00 pm and 12:00
- •am over the 4 weeks prior to Screening through to Day -2
- •9. Subjects must have been sleeping at least 6 to 8 hours per night over the 4
- •weeks prior to Screening through to Day -2
排除标准
- •Subjects meeting any of the following exclusion criteria will not be enrolled
- •in the study:
- •1. Clinically significant abnormality within 2 years of Screening that in the
- •Investigator*s opinion may place the subject at risk or interfere with study
- •outcome variables; this includes, but is not limited to, history of or current
- •cardiac, renal, neurologic, gastrointestinal, pulmonary, endocrinologic,
- •hematologic, or immunologic disease or history of malignancy
- •2. History of convulsions (other than benign febrile convulsions of childhood)
- •including epilepsy, or personal history of significant cerebral trauma or
- •central nervous system infections (e.g., meningitis)
- •3. History or evidence of significant ophthalmologic or neurologic condition
- •that would adversely affect the eye movement assessments
- •4. History or evidence of any medical condition potentially altering the
- •absorption, metabolism, or elimination of drugs; this includes a surgical
- •history of the gastrointestinal tract affecting gastric motility or altering
- •the gastrointestinal tract
- •5. Any of the following cardiovascular conditions at Screening or Day *2:
- •a. History or evidence of any of the following:
- •i. Myocardial infarction
- •ii. Cardiac valvulopathy
- •iii. Cardiac surgery revascularization (coronary artery bypass grafting or
- •percutaneous transluminal coronary angioplasty)
- •iv. Unstable angina
- •v. Cerebrovascular accident or stroke or transient ischemic attack
- •vi. Pacemaker
- •vii. Atrial fibrillation, flutter, or non-sustained or sustained ventricular
- •tachycardia
- •viii. Pulmonary arterial hypertension
- •ix. Sick sinus syndrome, second- or third-degree atrioventricular block
- •x. Uncontrolled hypertension
- •xi. Congestive heart failure
- •xii. Family history of sudden death or personal history of long QT syndrome
- •xiii. Hypokalemia
- •xiv. Unexplained syncope or syncope within the last 3 years regardless of
- •b. Electrographically and clinically significant abnormalities, as judged by
- •the Investigator, that might interfere with ECG analysis, including evidence of
- •a previous myocardial infarction, significant left ventricular hypertrophy,
- •flat T waves (particularly in the inferior leads), or more than minor
- •non-specific ST-T*wave changes
- •c. Rhythm other than sinus rhythm
- •d. Mean HR <50 beats per minute (bpm) or >100 bpm
- •e. Mean systolic blood pressure >140 mm Hg; mean diastolic blood pressure >90
- •f. QTc interval using Fridericia*s formula (QTcF) >450 msec in males or >470
- •msec in females
- •g. QRS interval *120 msec
- •h. PR interval >200 msec
- •6. Reports having experienced suicidal ideation (Type 4 or 5 on the C-SSRS)
- •within 30 days prior to Screening, any suicidal behavior within 2 years prior
- •to Screening (any *Yes* answers on Suicidal Behavior section of C-SSRS), and/or
- •the Investigator assesses the subject to be a safety risk to him/herself or
- 另有 6 项未显示
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