A First Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Target Engagement of Single Doses of NNC6022-0001 in Healthy Adults.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Number of treatment emergent adverse events (TEAE)
研究概览
简要总结
The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases.
The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine.
Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.
The study will last for about 10 months in total.
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
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women of non-childbearing potential.
- •Age 18-55 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) between 18.5 to 29.9 kg/m^2 (both inclusive) at screening.
- •Body Weight: Greater than or equal to 50 kg at screening.
- •Considered to be generally healthy 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(s) or similar products.
- •Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values:.
- •Alanine Aminotransferase (ALT) above upper normal limit (UNL)
- •Aspartate aminotransferase (AST) above UNL
- •Total Bilirubin (BL) above UNL
- •Creatinine above UNL
- •International normalized ratio (INR) above UNL
- •Fibrinogen outside normal range of 1.6 - 4.2 gram pr. Liter (g/L)
- •C-reactive protein (CRP) above 5 milligram pr. Liter (mg/L) (males) and above 8 mg/L (females)
- •Use of prescription medicinal products or vaccines within 14 days before dosing and/or non prescription medicinal products within 7 days before dosing.
- •Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
研究组 & 干预措施
NNC6022-0001
Participants will be randomised to NNC6022-0001.
干预措施: NNC6022-0001 (Drug)
Placebo (NNC6022-0001)
Participants will be randomised to placebo.
干预措施: Placebo (NNC6022-0001) (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAE)
时间窗: From time of dosing (Day 1) to end of study (Day 14)
Number of events
次要结局
- AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose(From pre-dose (Day 1) to end of exposure (Day 7))
- AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (Day 1) to end of exposure (Day 7))
- IL-1β, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline(From pre-dose (Day 1) to estimated tmax (Day 1))
- Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose(From pre-dose (Day 1) to end of exposure (Day 7))