A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of adverse events (AEs)
研究概览
简要总结
This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Body mass index 18.0-28.0 kg/m^2
- •Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) 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 randomised
- •Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator
- •Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
研究组 & 干预措施
Dose level 1
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin 287 (Drug)
Dose level 1
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin glargine (Drug)
Dose level 1
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: placebo (Drug)
Dose level 2
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin 287 (Drug)
Dose level 2
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin glargine (Drug)
Dose level 2
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: placebo (Drug)
Dose level 3
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin 287 (Drug)
Dose level 4
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin glargine (Drug)
Dose level 3
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin glargine (Drug)
Dose level 3
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: placebo (Drug)
Dose level 4
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin 287 (Drug)
Dose level 4
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: placebo (Drug)
Dose level 5
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin 287 (Drug)
Dose level 5
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin glargine (Drug)
Dose level 5
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: placebo (Drug)
Dose level 6
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin 287 (Drug)
Dose level 6
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin glargine (Drug)
Dose level 6
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: placebo (Drug)
Dose level 7
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin 287 (Drug)
Dose level 7
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: insulin glargine (Drug)
Dose level 7
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
干预措施: placebo (Drug)
结局指标
主要结局
Number of adverse events (AEs)
时间窗: As recorded from trial product administration and until completion of Sub-visit 2G (Day 13)
次要结局
- Area under the serum insulin concentration-time curve(From 0 to 648 hours after a single dose)
- Area under the glucose infusion rate (GIR)-time curve(From 0 to 24 hours after a single dose)