Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Japanese and Non-Asian Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men.
Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by chance. Non-Asian participants will get NNC0194-0499.
Participants will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on the stomach.
The study will last for a maximum of 66 days. Participants will have 8 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).
The study includes blood sampling. Participants will not be able to take part in the study if the study doctor thinks there is a risk for participants 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)
盲法说明
The non-Asian part is run in parallel to the Japanese part in an open design. The Japanese part is double-blinded. Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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
- •Male, aged 20-55 years (both inclusive) at the time of signing informed consent
- •For Japanese subjects only, both parents of Japanese descent. For non-Asian subjects only, both parents of non-Asian descent
- •Body mass index (BMI) between 23.0 and 34.9 kg/m^2 (both inclusive)
- •Body weight greater than or equal to 60 kg
排除标准
- •Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- •Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease risk (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) greater than or equal to 5 percentage
研究组 & 干预措施
NN0194-0499
Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo, Asian participants will only receive NNC0194-0499. There will be 3 cohorts with escalating dose levels. There should be at least 4 days between dose administration of the last participant in a dose level cohort and dose administration of the first participant in the following dose level cohort.
干预措施: NNC0194-0499 (Drug)
Placebo
Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo.
干预措施: Placebo (NNC0194-0499 ) (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs)
时间窗: From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36)
Count of events
次要结局
- AUC0-168h, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single s.c. administration(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- tmax, SD: Time from dose administration to maximum serum concentration of NNC0194-0499 after a single s.c. administration(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- Vz/FSD: 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))
- MRTSD: The mean residence time of NNC0194-0499 after a single s.c. administration(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- AUC0-∞, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- Cmax, SD: Maximum concentration of NNC0194-0499 in serum after a single s.c. administration(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- t½, SD: Terminal half-life of NNC0194-0499(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- CL/FSD: Apparent total serum clearance of NNC0194-0499(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- AUC0-tz, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to the time of the last quantifiable sample after a single s.c. administration(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))