NCT03015207已完成1 期
A Randomised, Double-blinded, Single-dose, Dose-escalation, First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or 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
- 56
- 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. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.
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
- 22 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, aged 22-55 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). Overweight should be due to excess adipose tissue, as judged by the investigator
排除标准
- •Any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
- •Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology /American Heart Association) guideline) risk above or equal to 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 (visit 1) until 3 months following administration of the investigational medical product
- •Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid
研究组 & 干预措施
NNC0194-0499
Experimental
Injected s.c. /subcutaneously (under the skin)
干预措施: NNC0194-0499 (Drug)
Placebo
Placebo Comparator
Injected s.c. /subcutaneously (under the skin)
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 time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)
次要结局
- The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration(From pre-dose (day 1) until the followup (day 36))
- The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration(From pre-dose (day 1) until the followup (day 36))
- The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration(From pre-dose (day 1) until the followup (day 36))
研究者
研究点 (1)
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