ACTRN12615000117516尚未招募不适用
A Phase I Double-Blind, Randomised, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UE2343 in Healthy Subjects.
Actinogen Medical0 个研究点目标入组 24 人开始时间: 2015年2月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Healthy male and female subjects (of non-childbearing potential) aged 18 – 65 years of age.
- •Female subjects of non-child bearing potential with negative pregnancy test at the Screening Visit. For the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy). Menopausal status will be confirmed by demonstrating at screening that levels of follicle stimulating hormone (FSH) fall within the respective pathology reference range. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the Principal Investigator following consultation with the Sponsor’s Responsible Physician.
- •Male subjects willing to use 2 effective method of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months after last dose on Day 10.
- •Subject with a Body Mass Index (BMI) of 18-30 kg/m2.
- •Body Mass Index = Body weight (kg) / [Height (m)]2.
- •Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values or results suggesting an infectious or other systemic disorder within 28 days of the first dose on Day 1. Subjects with negative urinary drugs of abuse screen or a negative alcohol breath test within 28 days of the first dose on Day 1. (N.B. a positive alcohol result may be repeated at the discretion of the Investigator).
- •Subject with negative HIV and Hep B and Hep C results.
- •Subject with no clinically significant abnormalities in 12-lead ECG within 28 days of the first dose on Day 1.
- •Subject with no clinically significant abnormalities in vital signs (blood pressure, heart rate, respiration rate and oral temperature) within 28 days of the first dose on Day 1.
- •Subjects must be willing and able to comply with the requirements of the protocol and must be available to complete the study.
- •Subject must satisfy a medical examiner about their fitness to participate in the study.
- •Subject must provide written informed consent to participate in the study.
排除标准
- •Any relevant abnormality in medical history or on examination, including history of dementia, or other psychiatric, neurological, immunological, respiratory or cardiovascular disorder. Abnormal laboratory findings suggesting the presence of a systematic disorder.
- •Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 60 days prior to the first study drug administration or five half-lives, whichever is longer.
- •History of any significant (as determined by the investigator) allergic reaction including allergy to lidocaine (for Part 3 of the study only) and excipients associated with UE2343.
- •Subjects with clinical evidence of peripheral neuropathy or clinically significant nerve conduction abnormalities.
- •Recent or clinically significant history of drug or alcohol abuse.
- •Use of more than 1-2 tobacco/nicotine-containing products per month within 6 months prior to the first study drug administration.
- •Whole blood donation or significant blood loss within 3 months from expected dose administration or plasma donation within 14 days of study drug administration.
- •Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
- •Receipt of regular prescribed medication and/or receipt of vitamins, minerals, herbal remedies and nutritional supplements within 7 days of the first study day. Subjects taking long lasting drugs more than 7 days before the study may be excluded at the physician’s discretion. Inclusion of subjects who have taken over the counter medication during this period will be reviewed on a case-by-case basis in relation to the safety aspects and objectives of this study.
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