Investigation of Safety, Tolerability and Pharmacokinetics of Subcutaneously Co-administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Japanese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 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 study looks at how the new medicine called NNC0480-0389 works in the body of Japanese men when it is given together with semaglutide. Participants will get NNC0480-0389 and semaglutide or 2 doses of placebo - which treatment participants get is decided by chance. NNC0480-0389 is a new medicine that has not been previously approved. It means that the medicine has not yet been approved by the health authorities. Semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels in patients with type 2 diabetes. NNC0480-0389 is being developed to be given together with semaglutide.NNC0480-0389 targets a different part of the system that regulates sugar levels in the body than semaglutide. Therefore, it is expected that together NNC0480-0389 and semaglutide will more effectively lower sugar levels in the blood. Participants will get 2 injections of the study medicine. It will be injected with a needle into a skin fold on participants' stomach. The study will last for a maximum of 72 days. Participants will have 10 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).The study includes blood sampling.
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
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male aged 20-55 years (both inclusive) at the time of signing the informed consent.
- •Both parents of Japanese descent.
- •Body mass index between 20.0 kg/m^2 and 24.9 kg/m^2 (both inclusive).
- •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 subject's safety or compliance with the protocol.
- •Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening.
- •Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
研究组 & 干预措施
1.7 mg NNC0480-0389 + 0.5 mg Semaglutide
Participants will be co-administered single doses of 1.7 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
干预措施: NNC0480-0389 (Drug)
1.7 mg NNC0480-0389 + 0.5 mg Semaglutide
Participants will be co-administered single doses of 1.7 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
干预措施: Semaglutide (Drug)
Placebo (1.7 mg NNC0480-03899) + placebo (0.5 mg Semaglutide)
Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.
干预措施: Placebo (NNC0480-0389) (Drug)
Placebo (1.7 mg NNC0480-03899) + placebo (0.5 mg Semaglutide)
Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.
干预措施: Placebo (Semaglutide) (Drug)
8.6 mg NNC0480-0389 + 0.5 mg Semaglutide
Participants will be co-administered single doses of 8.6 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
干预措施: NNC0480-0389 (Drug)
8.6 mg NNC0480-0389 + 0.5 mg Semaglutide
Participants will be co-administered single doses of 8.6 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
干预措施: Semaglutide (Drug)
Placebo (8.6 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)
Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.
干预措施: Placebo (NNC0480-0389) (Drug)
Placebo (8.6 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)
Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.
干预措施: Placebo (Semaglutide) (Drug)
30 mg NNC0480-0389 + 0.5 mg Semaglutide
Participants will be co-administered single doses of 30 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
干预措施: NNC0480-0389 (Drug)
30 mg NNC0480-0389 + 0.5 mg Semaglutide
Participants will be co-administered single doses of 30 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
干预措施: Semaglutide (Drug)
Placebo (30 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)
Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.
干预措施: Placebo (NNC0480-0389) (Drug)
Placebo (30 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)
Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.
干预措施: Placebo (Semaglutide) (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs)
时间窗: From time of dosing (day 1) until completion of the follow-up visit (day 43)
Count of events
次要结局
- AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose(From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43))
- Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 upon a single-dose(From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43))
- AUC0-∞,semaglutide,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose(From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43))
- Cmax,semaglutide,SD: Maximum plasma concentration of semaglutide upon a single-dose(From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43))