NL-OMON52117已完成不适用
A Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ENX-102 at Plasma Steady State in Healthy Volunteers - MAD to evaluate safety, tolerability, PK and PD of ENX-102 in HV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
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
- •- Healthy male and female volunteers aged 18 to 55 years, inclusive, at
- •- Capable of giving written informed consent
- •- Willing to give written consent to have data entered into Verified Clinical
- •- 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 -1; 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 -1 through 3 months
- •after the last dose of study drug, and with a negative pregnancy test at
- •Screening and Day -1
- •- 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 -1 through 3 months
- •after the last dose of study drug
- •- Body mass index of 18 to 35 kg/m2 at Screening
- •- Willing and able to comply with all study requirements including the
- •a. Reside in the inpatient unit from Day -1 until discharge on Day 13
- •b. Refrain from strenuous exercise from Day -4 until Day 26
- •c. Abstain from grapefruit , alcohol , caffeine , or xanthine containing
- •products from Day -4 through Day 26
排除标准
- •- 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
- •- Reports having experienced suicidal ideation (Type 4 or 5 on the CSSRS)
- •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 others
- •- History or evidence of moderate or severe Substance Use Disorder as defined
- •by the Diagnostic and Statistical Manual of Mental Disorders (5th Edition)
- •- Clinically significant abnormal findings in serum chemistry, coagulation,
- •hematology, or urinalysis results at Screening or Day -1
- •- Clinically significant abnormal findings in vital sign assessments at
- •Screening or Day -1
- •- History of hepatitis B or hepatitis C or demonstration of hepatitis B surface
- •antigen or hepatitis C antibody at Screening
- •- History of HIV infection or demonstration of HIV antibodies at Screening
- •- Receipt of an investigational drug within 90 days or 5 half*lives, whichever
- •is longer, prior to Day 1 or currently in the follow*up period of another
- •clinical trial at the time of Screening
- •- Any other condition that, in the Investigator's opinion, might indicate that
- •the subject is unsuitable for the study
研究者
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