First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (Single Dose)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male 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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy, non-smoking male subjects
- •BMI (body mass index) between 18.0 and 28.0 kg/m^2, both incl.
- •Body weight 50 to 100 kg, both incl.
排除标准
- •Strenuous exercise within 4 days prior to dosing
- •Receipt of any investigational medicinal product within 3 months prior to randomisation
研究组 & 干预措施
Single dose (SD)
Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation
干预措施: somapacitan (Drug)
Single dose (SD)
Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation
干预措施: placebo (somapacitan) (Drug)
Multiple dose (MD)
Multiple doses administered s.c. (subcutaneously, under the skin). All subjects will be dosed four times with a dosing frequency of once weekly. Escalation to the next dose level will be based on safety evaluation
干预措施: somapacitan (Drug)
Multiple dose (MD)
Multiple doses administered s.c. (subcutaneously, under the skin). All subjects will be dosed four times with a dosing frequency of once weekly. Escalation to the next dose level will be based on safety evaluation
干预措施: placebo (somapacitan) (Drug)
结局指标
主要结局
Incidence of adverse events (Single Dose)
时间窗: From first administration of trial product and up until day 40
Incidence of adverse events (Multiple Dose)
时间窗: From first administration of trial product and up until day 49
次要结局
- Area under the NNC0195-0092 (somapacitan) serum concentration-time curve(From 0 to 168 hours)
- Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)(up to day 40)
- Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)(up to day 40)
- Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve(From 0-168 hours)
- Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only)(From 0-240 hours)
- Maximum serum concentration (Cmax) for IGF-I(up to day 40)
- Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve(From 0-168 hours)
- Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only)(From 0-240 hours)
- Maximum serum concentration (Cmax) for IGFBP-3(up to day 40)
- Number of injection site reactions(From first administration of trial product and up until day 49 (MD part))