Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0174-0833 in Chinese Male Subjects Being Normal Weight, Overweight or With Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose
研究概览
简要总结
The aim of this study is to look at how the study medicine behaves in participants body and how it is removed from their body.
The study compares three different doses of the study medicine in Chinese healthy men.
Participant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get is decided by chance.
NNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation.
We are testing the study medicine to make a medicine that can help people lose weight.
Participant will get 1 injection by a study nurse or doctor at the clinic. The injection will be with a needle in a skin fold in the stomach area.
The study will last for about 5 months. But participants participation will last about 2 months.
Participant will have 8 clinic visits with the study staff. One of these visits will be a 7-day, 6-night stay.
At all visits, except the information visit, participant will have blood drawn along with other clinical examinations.
Participants will be asked about their health, medical history and habits including mental health.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NNC0174 0833 1.8 mg
Each participant will receive one single dose of NNC0174 0833
干预措施: NNC0174 0833 (Drug)
NNC0174 0833 0.9 mg
Each participant will receive one single dose of NNC0174 0833
干预措施: NNC0174 0833 (Drug)
NNC0174 0833 0.3 mg
Each participant will receive one single dose of NNC0174 0833
干预措施: NNC0174 0833 (Drug)
结局指标
主要结局
AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose
时间窗: From pre-dose (Day 1) to Visit 7 (Day 36)
measured in h·nmol/L
次要结局
- Change in body weight(From pre-dose (Day 1) to Visit 7 (Day 36))
- AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose(From pre-dose (Day 1) to Visit 3 (Day 8))
- t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833(From pre-dose (Day 1) to Visit 7 (Day 36))
- CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833(From pre-dose (Day 1) to Visit 7 (Day 36))
- Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma(From pre-dose (Day 1) to Visit 7 (Day 36))
- tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833(From pre-dose (Day 1) to Visit 7 (Day 36))
- Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase(From pre-dose (Day 1) to Visit 7 (Day 36))