Investigation of Pharmacokinetic Properties of Single Doses of NNC0662-0419 in Japanese, Chinese and Non-Asian Participants Living With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- AUC; The area under the NNC0662-0419 plasma concentration-time curve
研究概览
简要总结
The study is testing the new medicine NNC0662-0419 in people living with overweight or obesity. The purpose of the study is to look into the amount of the new medicine NNC0662-0419 in participants blood after one dose. And also look into how safe and how well the study medicine is tolerated in people living with overweight or obesity. NNC0662-0419 is a new medicine which cannot be prescribed by doctors. NNC0662-0419 is currently being tested in humans and the dose participants will receive has been found safe and tolerable. Participants will get a single dose of NNC0662-0419 given by study staff as a single injection under participants skin. Like all medicines, the study medicine may have side effects. The study will last up to 2 months.
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
- 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
- 否
入选标准
- •Male or female (sex at birth) Japanese, Chinese or non-Asian participants (all self-reported).
- •For Japanese participants: both parents of Japanese descent.
- •For Chinese participants: both parents of Chinese descent.
- •For non-Asian participants: both parents of non-Asian descent (non-Asian is defined as of countries outside of Asia).
- •Age 18-55 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) between 24.0 and 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- •Considered eligible 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 a* or suspected hypersensitivity to study intervention(s) or related products.
- •Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- •2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 millisecond (msec), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 msec (females) or 430 msec (males), or any other clinically significant abnormal electrocardiogram (ECG) results as judged by the investigator, at screening.
- •Glycated haemoglobin (HbA1c) greater than or equal to >= 6.5percent (%) (48 millimoles per liter [mmol/mol]) at screening.
- •Calcitonin >= 50 nanogram per liter (ng/L) at screening. a* - As declared by the participant or reported in the medical records.
研究组 & 干预措施
NNC0662-0419 (Dose 1)
Participants will receive a single dose (SD) of NNC0662-0419 subcutaneously.
干预措施: NNC0662-0419 (Drug)
NNC0662-0419 (Dose 2)
Participants will receive a SD of NNC0662-0419 subcutaneously.
干预措施: NNC0662-0419 (Drug)
NNC0662-0419 (Dose 3)
Participants will receive a SD of NNC0662-0419 subcutaneously.
干预措施: NNC0662-0419 (Drug)
结局指标
主要结局
AUC; The area under the NNC0662-0419 plasma concentration-time curve
时间窗: From pre-dose on Day 1 until completion of the end of study visit (Day 29)
Measured in hours\*nanomoles per liter (h\*nmol/L).
次要结局
- Cmax; The maximum plasma concentration of NNC0662-0419(From pre-dose on Day 1 until completion of the end of study visit (Day 29))
- Number of treatment-emergent adverse events (TEAEs)(From time of dosing on Day 1 until completion of the end of study visit (Day 29))