A Randomised, Double-blinded, Single Subcutaneous Dose Escalation Trial Investigating the Safety and Tolerability of NNC9204-1513 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
The study is comparing the new medicine NNC9204-1513 with a standard therapy of glucagon (GlucaGen®). This is the first time NNC9204-1513 is given to humans.
Participants will either receive NNC9204-1513 or GlucaGen® - which treatment you get is decided by chance (like flipping a coin). Neither the participant nor the study doctor will know which study medicine (NNC9204-1513 or GlucaGen®) the participant is receiving (double -blinding). In case of emergency, this information will be readily available.
NNC9204-1513 is a new medicine for rescue treatment of severe low blood sugar and currently not available on the market (doctors cannot prescribe this medicine). The participant will receive two or three single injections below the skin. One injection will contain NNC9204-1513 or GlucaGen®. The other injection will include placebo - this is a product that looks like the actual study drug but without any active ingredients. If a third injection is given, this will contain NNC9204-1513 or placebo. NNC9204-1513 and GlucaGen® will be given using different devices and volumes. In order to mask these external differences, a "double dummy" approach will be used, that means when you get either of the study medicine (NNC9204-1513 or GlucaGen®) you will get another injection which contains no medicine called 'placebo' (it will not have any effect on the body). Dependent on the injection volume to be administered, injections are given by either syringe with needle or an injection pen (NovoPen Echo®). The study will last for up to 39 days.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, aged 18 -55 years (both inclusive), at the time of signing informed consent
- •Body mass index (BMI) between 18.5 and 28.0 kg/sqm (both inclusive)
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG 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, evaluation of results, or compliance with the protocol
- •Smoker (defined as a subject who is smoking at least one cigarette or equivalent daily) who is not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
- •Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
研究组 & 干预措施
NNC9204-1513
Participants will receive increasing doses of NNC9204-1513.
干预措施: NNC9204-1513 (Drug)
NNC9204-1513
Participants will receive increasing doses of NNC9204-1513.
干预措施: Placebo (Drug)
Glucagon
Participants will receive a single fixed dose of glucagon.
干预措施: Glucagon (Drug)
Glucagon
Participants will receive a single fixed dose of glucagon.
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 time of dosing (day 1) to completion of the safety follow-up visit (day 8)
Count of events
次要结局
- Change from baseline in body temperature(baseline (day 1), follow-up visit (day 8))
- Change from baseline in haematology(baseline (day 1), follow-up visit (day 8))
- Change from baseline in biochemistry(baseline (day 1), follow-up visit (day 8))
- Change from baseline in glucose metabolism(baseline (day 1), follow-up visit (day 8))
- Change from baseline in Physical examination(baseline (day 1), follow-up visit (day 8))
- Incidence of injection site reactions(After administration of the trial products (day 1) until completion of the post-treatment follow-up visit (day 8).)
- Change from baseline in fibrinogen(baseline (day 1), follow-up visit (day 8))
- Change from baseline in lipids(baseline (day 1), follow-up visit (day 8))
- Change from baseline in systolic- and diastolic blood pressure(baseline (day 1), follow-up visit (day 8))
- Change from baseline in respiration rate(baseline (day 1), follow-up visit (day 8))
- Change from baseline in 12-lead electrocardiogram (ECG) heart rate(baseline (day 1), follow-up visit (day 8))
- Change from baseline in 12-lead ECG (RR interval)(baseline (day 1), follow-up visit (day 8))
- Change from baseline in 12-lead ECG (PR interval)(baseline (day 1), follow-up visit (day 8))
- AUC0-15min,SD, area under the plasma concentration time curve(0 to 15 minutes after single dose)
- t1/2,SD, terminal half-life(Measured for 24 hours after administration of a single s.c. dose)
- Onset of appearance(Measured for 24 hours after administration of a single s.c. dose)
- AUCPG,0-15min,SD, area under the plasma glucose time curve(0 to 15 minutes after single dose)
- ΔPG0-15min,SD, Increase in plasma glucose concentration from 0 to 15 minutes(0 to 15 minutes after single dose)
- Change from baseline in 12-lead ECG (overall evaluation)(baseline (day 1), follow-up visit (day 8))
- Change from baseline in hormones(baseline (day 1), follow-up visit (day 8))
- Change from baseline in urine dipstick parameter(baseline (day 1), follow-up visit (day 8))
- Change from baseline in 12-lead ECG (QRS interval)(baseline (day 1), follow-up visit (day 8))
- Change from baseline in 12-lead ECG (QTc intervals [Fridericia])(baseline (day 1), follow-up visit (day 8))
- Change from baseline in 12-lead ECG (QT interval)(baseline (day 1), follow-up visit (day 8))
- Change from baseline in prothrombin time(baseline (day 1), follow-up visit (day 8))
- Change from baseline in Activated Partial Thromboplastin time (APTT)(baseline (day 1), follow-up visit (day 8))