临床试验/NCT05599945

NCT05599945已完成1 期

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults and in Participants With Hepatic Steatosis

Novo Nordisk A/S2 个研究点分布在 1 个国家目标入组 48 人开始时间: 2022年11月23日最近更新: 2025年10月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 48
试验地点: 2
主要终点: Number of treatment emergent adverse events (TEAEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance.NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 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: All
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Single Dose 4: NNC0581-0001 250 mg

Experimental

Part A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.

干预措施: Placebo (NNC0581-0001) (Drug)

Single Dose 1: NNC0581-0001 10 milligram (mg)

Experimental

Part A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.

干预措施: NNC0581-0001 (Drug)

Single Dose 1: NNC0581-0001 10 milligram (mg)

Experimental

Part A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.

干预措施: Placebo (NNC0581-0001) (Drug)

Single Dose 2: NNC0581-0001 30 mg

Experimental

Part A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.

干预措施: NNC0581-0001 (Drug)

Single Dose 2: NNC0581-0001 30 mg

Experimental

Part A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.

干预措施: Placebo (NNC0581-0001) (Drug)

Single Dose 3: NNC0581-0001 90 mg

Experimental

Part A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.

干预措施: NNC0581-0001 (Drug)

Single Dose 3: NNC0581-0001 90 mg

Experimental

Part A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.

干预措施: Placebo (NNC0581-0001) (Drug)

Single Dose 4: NNC0581-0001 250 mg

Experimental

Part A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.

干预措施: NNC0581-0001 (Drug)

Single Dose 5: NNC0581-001 600 mg

Experimental

Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously.

干预措施: NNC0581-0001 (Drug)

Single Dose 5: NNC0581-001 600 mg

Experimental

Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously.

干预措施: Placebo (NNC0581-0001) (Drug)

Single Dose 6: NNC0581-001 1000 mg

Experimental

Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 1000 mg or matching placebo injection subcutaneously.

干预措施: NNC0581-0001 (Drug)

Single Dose 6: NNC0581-001 1000 mg

Experimental

Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 1000 mg or matching placebo injection subcutaneously.

干预措施: Placebo (NNC0581-0001) (Drug)

结局指标

主要结局

Number of treatment emergent adverse events (TEAEs)

时间窗: From dosing (Day 1) until completion of the End of Study Visit at week 52

Measured as number of events.

次要结局

tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose(From dosing (Day 1) to 168 hours after dosing)
AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose(From dosing (Day 1) to 168 hours after dosing)
Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose(From dosing (Day 1) to 168 hours after dosing)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (2)

Loading locations...

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