NL-OMON34913已完成不适用
*A Phase I, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and T-cell tolerizing effect of DC-TAB in healthy volunteers, after single and multiple dosing* - A phase I trial with DC-TAB
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
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 18 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;
- •The use of suitable anti conception in the 3 months before start of the study and you will remain using this until 3 months after the study and/or you can not invoke an pregnancy (males) or you can not get pregnant (females)
- •no abnormalities are diagnosed during the screening.
排除标准
- •If you are pregnant, planning to get pregnant or breastfeeding;
- •If you have relatives (1st degree) who have MS;
- •If you smoke 5 or more cigarettes per day or are not able to stop smoking during the admission period;
- •If you have abused drug (past and present) and or alcohol
- •The use of prescribed medication in the 14 days before start of the study, except for hormone based anticonceptionals, standard vitamines and paracetamol;
- •If you recieved a vaccination within the 4 weeks before the start of the study;
- •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 have donated plasma in the 7 days before admission;
- •if you have recieved bloodproducts in the 6 month before start of start of the study;
- •you are Hepatitis B, C or HIV positive;
- •If no immune response can be achieved by DC-TAB in your blood;
- •you are not suitable to participate in this study according to the investigator.
研究者
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