A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Subcutaneous Single Ascending Doses of NNC0650-0013 in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- S.C. Cohort: Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks.
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)
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years (both inclusive) at the time of signing the informed consent.
- •Body mass index between 24.0 and 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
- •Considered to be otherwise 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, unwillingness or inability, which, in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- •Glycated haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole (mmol/mol)) at screening.
研究组 & 干预措施
Placebo
Participants will receive matching placebo to NNC0650-0013 subcutaneously.
干预措施: Placebo (Drug)
NNC0650-0013: Subcutaneous dose
Participants will receive NNC0650-0013 subcutaneously in an ascending dose manner.
干预措施: NNC0650-0013 A (Drug)
NNC0650-0013: Intravenous dose
Participants will receive NNC0650-0013 in an ascending dose manner intravenously.
干预措施: NNC0650-0013 A (Drug)
结局指标
主要结局
S.C. Cohort: Number of treatment emergent adverse events (TEAEs)
时间窗: From time of dosing (day 1) until completion of the follow-up visit (day 75)
Measured as number of events.
次要结局
- S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow up visit (day 75))
- S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered(From pre-dose (day1) until completion of the follow-up visit (day 75))