NCT01054937已完成1 期
First-in-Man, Randomised, Double-Blind, Placebo-Controlled, Single Dose Escalation Study of the Novel Compound 4SC-203 in Young Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 4SC AG
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Investigation of safety and tolerability of escalating single doses of 4SC-203.
研究概览
简要总结
The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 18 to 45 years (included), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
- •Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and to understand and sign the written informed consent
排除标准
- •Evidence of current or previous clinically significant disease, medical condition or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator would compromise the safety of the subject or the quality of the data
- •Current or recent history of significant renal, hepatic, haematological, immunological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the subject's participation in the trial
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
4SC-203
Experimental
干预措施: 4SC-203 (Drug)
结局指标
主要结局
Investigation of safety and tolerability of escalating single doses of 4SC-203.
时间窗: 14 days
次要结局
- To investigate the pharmacokinetics of single doses of 4SC-203.(14 days)
- To assess the pharmacodynamic effect by means of appropriate biomarkers.(14 days)
研究者
研究点 (1)
Loading locations...
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