A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NNC4005-0001 in Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Treatment-emergent adverse event (TEAEs)
研究概览
简要总结
The purpose of this clinical study is to find out if NNC4005-0001 is well-tolerated and safe for people who have increased body weight and increased liver fat. Participants will receive either NNC4005-0001, which is the treatment being tested, or a placebo, which is a treatment that contains no active medicine. The study will last for about for about 7 to 8 months.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-69 years (both inclusive) at the time of signing the informed consent.
- •Body Mass Index (BMI) of 27.0-40.0 kilogram per square meter (kg/m^2) (both inclusive) at screening process.
- •Hepatic fat fraction greater than or equal to (≥) 8% by magnetic resonance imaging proton density fat fraction (MRI-PDFF) within 17 days prior to dosing.
- •No prior or present clinical history of metabolic dysfunction-associated steatohepatitis (MASH) diagnosis.
排除标准
- •Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Previous or current use of therapies for MASH or antifibrotic therapies (authorised or within aclinical trial).
- •Use of high-dose vitamin E [greater than (>) 800 international unit (IU) per day], glucagon-like peptide-1 (GLP-1) agonists (such as liraglutide, dulaglutide, or semaglutide), glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 agonists (such as tirzepatide), or pioglitazone within 6 months prior to screening.
- •Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels greater than or equal (≥) 1.5× Upper Limit of Normal (ULN) at screening.
- •Total bilirubin levels > 1.5 times ULN if direct bilirubin is within Normal Limits (WNL) at screening.
研究组 & 干预措施
NNC4005-0001
Participants will receive a single dose of NNC4005-0001 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts.
干预措施: NNC4005-001 (Drug)
Placebo
Participants in each cohort will receive placebo matched to NNC4005-0001 injected subcutaneously.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Treatment-emergent adverse event (TEAEs)
时间窗: From dosing (day 1) until compeletion of end of study (EOS) visit on day 169
Measured as count of events
次要结局
- AUC(0-last): The area under the NNC4005-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose(From dosing (day 1) to 48 hours post-dose)
- Cmax: The maximum concentration of NNC4005-0001 in plasma(From dosing (day 1) to 48 hours post-dose)
- tmax: The time from dose administration to the maximum plasma concentration of NNC4005-0001(From dosing (day 1) to 48 hours post-dose)
- t1/2: Half life(From dosing (day 1) to 48 hours post-dose)
- CLr: Renal clearance(From dosing (day 1) to 48 hours post-dose)