Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injections of NNC0582-0001 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
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with six sequential single dose cohorts with ascending dose levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single subcutaneous administrations of NNC0582-0001 and explores the pharmacodynamics in healthy participants. Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0582 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
- •Body Mass Index (BMI) from 20.0 to 30.0 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
- •Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimoles per mole [mmol/mol]) at screening.
- •Any of the below laboratory safety parameters at screening outside normal range, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters):
- •Alanine aminotransferase (ALT)
- •Aspartate aminotransferase (AST)
- •Bilirubin
- •Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73m^2 (mL/min/1.73m^2)
研究组 & 干预措施
Single Dose 3: NNC0582-0001 90 mg
Participants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously.
干预措施: Placebo (Drug)
Single Dose 3: NNC0582-0001 90 mg
Participants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously.
干预措施: NNC0582-0001 (Drug)
Single Dose 1: NNC0582-0001 10 milligram (mg)
Participants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously.
干预措施: NNC0582-0001 (Drug)
Single Dose 1: NNC0582-0001 10 milligram (mg)
Participants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously.
干预措施: Placebo (Drug)
Single Dose 2: NNC0582-0001 30 mg
Participants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously.
干预措施: NNC0582-0001 (Drug)
Single Dose 2: NNC0582-0001 30 mg
Participants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously.
干预措施: Placebo (Drug)
Single Dose 4: NNC0582-0001 250 mg
Participants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously.
干预措施: NNC0582-0001 (Drug)
Single Dose 4: NNC0582-0001 250 mg
Participants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously.
干预措施: Placebo (Drug)
Single Dose 5: NNC0582-0001 600 mg
Participants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously.
干预措施: NNC0582-0001 (Drug)
Single Dose 5: NNC0582-0001 600 mg
Participants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously.
干预措施: Placebo (Drug)
Single Dose 6: NNC0582-0001 1000 mg
Participants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously.
干预措施: NNC0582-0001 (Drug)
Single Dose 6: NNC0582-0001 1000 mg
Participants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously.
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 dosing (Day 1) until End of Study visit (Week 52)
Measured as number of events.
次要结局
- AUC0-∞: The area under the NNC0582-0001 plasma concentration-time curve from time zero to infinity after a single dose.(From dosing (Day 1) to 168 hours after dosing)
- Cmax: The maximum concentration of NNC0582-0001 in plasma(From dosing (Day 1) to 168 hours after dosing)
- tmax: The time from dose administration to maximum plasma concentration of NNC0582-0001(From dosing (Day 1) to 168 hours after dosing)