NCT03095807已完成1 期
Investigation on Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 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 trial is conducted in the United States of America (USA). The aim of this trial is to assess the safety and tolerability of single doses of NNC9204-1706 administered subcutaneously in male subjects being overweight or with obesity.
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
- 否
入选标准
- •Male subjects aged 18-55 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator
排除标准
- •Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
- •Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk equal to or above 5%
- •Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) and who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product
研究组 & 干预措施
NNC9204-1706 A
Experimental
干预措施: NNC9204-1706 A (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events (TEAEs)
时间窗: From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13)
Count and % of events
次要结局
- Maximal observed concentration of the NNC9204-1706 plasma concentration curve(Day 1- Day 7)
- The apparent volume of distribution of NNC9204-1706(Day 1- Day 7)
- Changes in Body weight(Day 1, Days 10-13)
- Number of injection-site reactions(From the time of dosing (Day 1) to the follow-up visit (Days 10-13))
- Number of hypoglycaemic episodes(from time of dosing (Day 1) to the follow-up visit (Days 10-13))
- Area under the NNC9204-1706 plasma concentration-time curve(Day 1- Day 7)
- Area under the NNC9204-1706 plasma concentration-time curve (0-24h)(Day 1- Day 7)
- Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)(Day 1- Day 7)
- The apparent total plasma clearance of NNC9204-1706(Day 1- Day 7)
- Time to observed maximum concentration of NNC9204-1706 in plasma(Day 1- Day 7)
- Mean residence time of NNC9204-1706(Day 1- Day 7)
- Terminal half-life of NNC9204-1706(Day 1- Day 7)
研究者
研究点 (1)
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