jRCT2071240029进行中（未招募）不适用
A placebo-controlled, within-group randomised, and double-blind trial investigating safety, tolerability, and pharmacokinetics of FE 999301 after single ascending doses in healthy Japanese men
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 主要终点
- Number of treatment-emergent adverse events
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
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Japanese men with 18 to 45 years of age at screening
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations, as assessed by the investigator (or delegated person) at screening and on Day -1
排除标准
- •History of clinically significant medical conditions including, but not limited to, diseases of the renal, hepatic, respiratory, gastrointestinal, cardiovascular, neurological, musculoskeletal, immunological, haematological, endocrine, and metabolic systems, as well as oncological, psychiatric, dermatological, and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
结局指标
主要结局
Number of treatment-emergent adverse events
Including type, intensity, and causality
Change from baseline in vital signs, 12-lead electrocardiogram (ECG), haematology, clinical chemistry, haemostasis, and urinalysis parameters
After a single IV dose infusion
次要结局
未报告次要终点
研究者
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