A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Intravenous Administrations of NNC0642-1895 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAE)
研究概览
简要总结
This study is testing a new medicine, in healthy adults to assess its safety and understand how it behaves in the body. The purpose of this study is to evaluate the safety, tolerability, and how the body responds to a single dose of NNC0642-1895 in healthy adults. Participant will either get study medicine (NNC0642-1895) or placebo (a treatment that has no active medicine in it). Which treatment a participant receives is decided by chance. NNC0642-1895 is a new medicine that is being tested in humans for the first time and is not currently available for doctors to prescribe. The study will last for about 94 days (approximately 14 weeks).
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
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female (sex assigned at birth, inclusive of all gender identities).
- •Age 18-55 years (both inclusive) at the time of signing the informed consent.
- •Body Mass Index (BMI) between 18.5 to 29.9 kilogram per square meter (kg/m^2) (both inclusive) 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 related products.
- •Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
- •Alanine aminotransferase (ALT) greater than (>) Upper limit of normal (ULN) +10 percent (%)
- •Aspartate aminotransferase (AST) > ULN +20%
- •Bilirubin > ULN +20%
- •Creatinine > ULN +10%
- •Absolute neutrophil count > ULN
- •Absolute neutrophil count less than (<) Lower limit of normal (LLN)
- •Platelet count > ULN
- •Platelet count < LLN
- •Supine blood pressure at screening outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic
- •Heart rate outside the range of 50-90 beats/min at screening
- •Use of prescription (except contraceptives) or non-prescription medicinal products within 14 days before screening. Occasional use of over-the-counter acetaminophen or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) at their labelled doses is permitted.
研究组 & 干预措施
NNC0642-1895
Participants will be administered a single dose of NNC0537-1482 intravenously.
干预措施: NNC0642-1895 (Drug)
Placebo
Participants will receive placebo matched to NNC0642-1895 intravenously.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAE)
时间窗: From pre-dose (Day 1) to Day 66
Measured as number of events.
次要结局
- AUC0-∞; the area under the NNC0642-1895 serum concentration-time curve from time 0 to infinity after a single dose(From pre-dose (Day 1) to Day 66)
- Cmax; the observed maximum serum concentration of NNC0642-1895 after a single dose(From pre-dose (Day 1) to Day 66)