A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Target Engagement of Single and Multiple Oral Administrations of NNC0705-0001 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- PART A: Number of treatment emergent adverse events (TEAE)
研究概览
简要总结
The study is testing a new study medicine (called NNC0705-0001), as a potential medicine to treat chronic systemic inflammation, which is known for increasing the risk of developing cardiometabolic diseases. The aim of this study is to see if the study medicine is safe, how it works in our body, and what our body does to the study medicine. The participant will either get NNC0705-0001 or placebo (a "dummy medicine" without the active ingredient). Which treatment the participant gets is decided by chance. The study consists of 3 parts: PART A - single ascending dose (SAD); PART B - multiple ascending doses (MAD) and PART C - food effect (FE) on the pharmacokinetic (PK) properties of NNC0705-0001 and will last about 35 days (PART A) and 41 days (PART B and C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Men, or women of non-childbearing potential.
- •Age 18-55 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) between 18.5 to 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
- •Body weight: greater than or equal to (≥) 50 kilogram (kg) 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
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values; Alanine Aminotransferase (ALT) greater than (>) Upper limit of normal (ULN); Aspartate aminotransferase (AST) > ULN; Total Bilirubin (BIL) > ULN; Creatinine > ULN; International normalized ratio (INR) > ULN; High-Sensitivity C-Reactive Protein (hsCRP) > 5 milligram per liter (mg/L) (males) and > 8 mg/L (females)
- •Use of prescription medicinal products or vaccines within 14 days before dosing and/or non-prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over the counter paracetamol and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
研究组 & 干预措施
Part A: NNC0705-0001
Participants will receive 6 different single ascending doses of NNC0705-0001 via oral administration.
干预措施: NNC0705-0001 (Drug)
Part A: Placebo
Participants will receive single ascending dose of placebo matching NNC0705-0001 via oral administration.
干预措施: Placebo (Drug)
Part B: NNC0705-0001
Participants will receive 4 different multiple ascending doses of NNC0705-0001 via oral administration.
干预措施: NNC0705-0001 (Drug)
Part B: Placebo
Participants will receive multiple ascending doses of placebo matching NNC0705-0001 via oral administration.
干预措施: Placebo (Drug)
Part C: NNC0705-0001
Participants will receive 2 separate single doses of NNC0705-0001 at a previously safety-cleared dose level in PART A, either in a fed or fasted state.
干预措施: NNC0705-0001 (Drug)
结局指标
主要结局
PART A: Number of treatment emergent adverse events (TEAE)
时间窗: From time of dosing (day 1) to end of study (day 7)
Measured in number of events.
PART B: Number of TEAEs
时间窗: From time of dosing (day 1) to end of study (day 13)
Measured in number of events.
AUC, SD; the area under the NNC0705-0001 plasma concentration-time curve after a single dose
时间窗: From pre-dose (day 1 or day 8) to day 2 or day 9
Measured in Hour x Micromole (hr×μM).
次要结局
- PART A: AUC0-t, SD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose(From pre-dose (day 1) to day 5)
- PART A: AUC0-∞, SD; the area under the NNC0705-0001 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (day 1) to day 5)
- PART A: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose(From pre-dose (day 1) to day 5)
- PART B: AUCtau, MD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to tau after the last dose(From pre-dose (day 7) to end of study (day 13))
- PART B: Cmax, MD; the maximum plasma concentration of NNC0705-0001 after last dose(From pre-dose (day 7) to end of study (day 13))
- PART C: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose(From pre-dose (day 1 or day 8) to day 2 or day 9)
- PART C: Number of TEAEs(From time of dosing (day 1) to end of study (day 12))