NL-OMON51720已完成不适用
A First in Human, Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Total Daily Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Intravenous Infusion of OMN6 in Healthy Subjects - CS0379-200475 Omnix
Omnix Medical0 个研究点目标入组 104 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
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 99（—）
入选标准
- •1. Provision of signed and dated, written informed consent prior to any
- •study-specific procedures.
- •2. Healthy male and female subjects aged 18 to 59 years (young population),
- •inclusive, or 60 years and older (elderly population) at the time of Screening.
- •3. A body mass index (BMI) between 18.0 to 28.0 kg/m2, inclusive at Screening.
- •4. Females must have a negative pregnancy test at Screening and on Day -1.
- •Woman of childbearing potential must be willing to use a highly effective
- •method of contraception with a failure rate of < 1% per year, be sexually
- •inactive or have a sterilized partner during the study and for at least 3
- •months after the (last) study drug administration. If a hormonal contraceptive
- •is used, it must have been initiated at least 1 month before the first study
- •drug administration. Woman of non-childbearing
- •potential will be confirmed at Screening by fulfilling one of the following
- •* Postmenopausal defined as amenorrhea for at least 12 months following
- •cessation of all exogenous hormonal treatments and with follicle-stimulating
- •hormone (FSH) levels >=30 mIU/mL.
- •* Documentation of irreversible surgical sterilization by hysterectomy,
- •bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- •5. Male subjects should be willing to use acceptable methods of double barrier
- •contraception i.e., condoms and spermicide, from Day 1 until at least 3 months
- •after the (last) study drug administration.
- •6. Male subjects must not donate sperm from Day 1 until at least 3 months after
- •the (last) study drug administration.
排除标准
- •1. History of any clinically important disease or disorder which, in the
- •opinion of the Investigator, may either put the subject at risk because of
- •participation in the study, or influence the results or the subject*s ability
- •to participate in the study.
- •2. Subject has creatinine clearance (according to Cockcroft-Gault formula) <90
- •mL/min (young population) of <60 mL/min (elderly population).
- •3. Any clinically important illness, medical/surgical procedure or trauma
- •within 4 weeks of the (first) administration of the study drug, as judged by
- •4. Any positive result at Screening for serum hepatitis B surface antigen,
- •hepatitis C antibody, and human immunodeficiency virus (HIV).
- •5. Female subject is pregnant or lactating.
- •6. Abnormal vital signs, after 10 minutes (semi-)supine rest at Screening or on
- •Day -1, defined as any of the following:
- •Systolic blood pressure >140 mmHg (young population) or >150 mmHg (elderly
- •population).
- •Diastolic blood pressure >90 mmHg.
- •Heart rate <40 or >100 bpm.
- •Two (2) re-tests may be performed at Screening or Day -1.
研究者
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