Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Chinese Males
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-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
研究概览
简要总结
This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's 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
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Chinese male aged 20-55 years (both inclusive) at the time of signing informed consent.
- •Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m^2) (both inclusive).
- •Body weight greater than or equal to 60 kg.
- •Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Known or suspected hypersensitivity to study intervention or related products.
- •Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
研究组 & 干预措施
NNC0194-0499 12 mg
Participants will receive a single subcutaneous (s.c.) dose of 12 milligrams (mg) NNC0194-0499 on Day 1.
干预措施: NNC0194-0499 (Drug)
NNC0194-0499 30 mg
Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
干预措施: NNC0194-0499 (Drug)
NNC0194-0499 96 mg
Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.
干预措施: NC0194-0499 (Drug)
结局指标
主要结局
AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
时间窗: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in nanomoles\*hours per liter (nmol h/L).
次要结局
- AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose(From Day 1 (pre-dose) until Day 7 (168 hours))
- t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- Relative change in triglycerides(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- Relative change in high-density lipoprotein (HDL) cholesterol(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- Relative change in low-density lipoprotein (LDL) cholesterol(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))