NCT02479022已完成1 期
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Number of treatment-emergent adverse events
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy subjects.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- •Body mass index 18.5-28.0 kg/m^2 (both inclusive)
- •Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms and clinical laboratory tests performed during the screening visit, as judged by the investigator
排除标准
- •Known or suspected hypersensitivity to trial products or related products
- •Previous participation in this trial. Participation is defined as signed informed consent
- •Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
- •Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) as judged by the investigator
研究组 & 干预措施
Level 1-7 escalating doses
Experimental
干预措施: Insulin 320 (Drug)
Level 1-7 escalating doses
Experimental
干预措施: insulin glargine (Drug)
Level 1-7 escalating doses
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events
时间窗: From the time of trial product administration and until 12 days after trial product administration
次要结局
- Area under the serum insulin concentration-time curve(From 0 to 288 hours after a single dose (SD))
- Area under the glucose infusion rate-time curve(From 0 to 24 hours after a single dose)
研究者
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