NL-OMON32600已完成不适用
*A randomized, double-blind, placebo-controlled Phase I study to evaluate the safety and tolerability of intrathecally administered single ascending bolus doses of Xen2174 in healthy subjects* - Phase I study with intrathecally administered single doses of Xen2174.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Xenome Ltd.
- 入组人数
- 35
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
- •you have given your written consent to take part in this study;
- •you are between 21 and 55 years of age (inclusive);
- •you are in good physical and mental health;
- •your body weight must be appropriate in relation to your height;
- •for female volunteers: you are not pregnant, nor can you get pregnant (you are surgically sterile or your uterus has been removed or you have been post-menopausal - if you are over 50 years old, your last menstrual period must be at least one year ago; if you are 50 years or younger, your last menstrual period must be more than two years ago);
- •no abnormalities are diagnosed during the screening.
排除标准
- •you drink more than 21 (male) or 14 (female) units of alcohol per week;
- •you are (or have been) taking illegal drugs and/or are (or have been) using alcohol to excess;
- •you have used prescribed medication in the 7 days before admission;
- •you have used over the counter medication in the 7 days before admission (exception paracetamol);
- •you have used medication, which makes you unsuitable to participate in this study;
- •females: if you are pregnant or lactating;
- •you have an abnormal EEG at screening or in the past;
- •you have taken part in another clinical drug study during the last 3 months prior to the study;
- •you have donated blood in the three months before admission;
- •you are Hepatitis B, C or HIV positive;
- •you or your releatives have or had epilepsy;
- •you have lost you consciences in the past (exception fainting);
- •you have had several blow to the head which could lead to brain damage;
- •you had meningitis or any other dissease that could be of influence on the brain;
- •you had chemotherapy or radiotherapy;
- •you have a bood difficiency;
- •you or your relatives have had a back abnormality, which makes you unsuitable to participate in this study;
- •you had an operation to the back, which makes you unsuitable to participate in this study;
- •you have a skin abnormality at the injection site;
- •you have received Xen2174 in the past;
- •you have a clinically significant medicine allergy or sensitivity;
- •you are not suitable to participate in this study according to the investigator;
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