A Single and Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics of MK-6024 in Healthy Chinese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
The goal of this study is to learn about the safety and whether people tolerate a study medicine called efinopegdutide. The study will also measure what happens to efinopegdutide in a healthy person's body over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The key inclusion criteria include but are not limited to the following:
- •Is in good health before randomization
- •Has a body mass index (BMI) ≥25 and ≤35 kg/m^2
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •Had major surgery, donated or lost approximately 400 mL blood within 4 weeks prior to entering the study
研究组 & 干预措施
Efinopegdutide Low Dose
Participants receive low dose efinopegdutide at a single dose on day 1
干预措施: Efinopegdutide (Drug)
Efinopegdutide Medium dose
Participants receive medium dose efinopegdutide at a single dose on day 1
干预措施: Efinopegdutide (Drug)
Efinopegdutide High Dose
Participants receive high dose efinopegdutide at a single dose on day 1
干预措施: Efinopegdutide (Drug)
Efinopegdutide Multiple Dose
Participants receive multiple doses of efinopegdutide over 78 days
干预措施: Efinopegdutide (Drug)
Placebo
Participants receive placebo to match efinopegdutide dose and regimen
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 112 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
时间窗: Up to approximately 78 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Maximum Plasma Concentration (Cmax) of Efinopegdutide- single dose
时间窗: At designated time points up to 35 days
Blood samples will be collected to determine the Cmax of efinopegdutide when administered as a single dose
Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- single dose
时间窗: At designated time points up to 35 days
Blood samples will be collected to determine the Tmax of efinopegdutide when administered as a single dose
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide- single dose
时间窗: At designated timepoints up to 35 days
Blood samples will be collected to determine the AUC0-last of efinopegdutide when administered as a single dose
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of Efinopegdutide- single dose
时间窗: At designated timepoints up to 35 days
Blood samples will be collected to determine the AUC0-inf of efinopegdutide when administered as a single dose
Terminal half life (t1/2) of Efinopegdutide- single dose
时间窗: At designated timepoints up to 35 days
Blood samples will be collected to determine the t1/2 of efinopegdutide when administered as a single dose
Apparent Clearance (CL) of Efinopegdutide- single dose
时间窗: At designated timepoints up to 35 days
Blood samples will be collected to determine the CL of efinopegdutide when administered as a single dose
Volume of Distribution (Vz) of Efinopegdutide- single dose
时间窗: At designated timepoints up to 35 days
Blood samples will be collected to determine the Vz of efinopegdutide when administered as a single dose
Maximum Plasma Concentration (Cmax) of Efinopegdutide- multiple dose
时间窗: At designated time points up to 112 days
Blood samples will be collected to determine the Cmax of efinopegdutide when multiple doses are administered
Apparent Clearance (CL) of Efinopegdutide- multiple dose
时间窗: At designated timepoints up to 112 days
Blood samples will be collected to determine the CL of efinopegdutide when multiple doses are administered
Minimum Plasma Concentration (Cmin) of Efinopegdutide- multiple dose
时间窗: At designated time points up to 112 days
Blood samples will be collected to determine the Cmin of efinopegdutide when multiple doses are administered
Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- multiple dose
时间窗: At designated time points up to 112 days
Blood samples will be collected to determine the Tmax of efinopegdutide when multiple doses are administered
Terminal half life (t1/2) of Efinopegdutide- multiple dose
时间窗: At designated timepoints up to 112 days
Blood samples will be collected to determine the t1/2 of efinopegdutide when multiple doses are administered
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide-multiple dose
时间窗: At designated timepoints up to 112 days
Blood samples will be collected to determine the AUC0-last of efinopegdutide when multiple doses are administered
Volume of Distribution at Steady State (Vss) of Efinopegdutide- multiple dose
时间窗: At designated timepoints up to 112 days
Blood samples will be collected to determine the Vss of efinopegdutide when multiple doses are administered
Area Under the Concentration-Time Curve to the end of the dosing period (AUC 0-tau)of Efinopegdutide- multiple dose
时间窗: At designated timepoints up to 78 days
Blood samples will be collected to determine the AUC0 to tau of efinopegdutide when multiple doses are administered
次要结局
- Change from Baseline in Weight(Baseline and day 112)
- Change from Baseline in HDL Cholesterol(Baseline and day 112)
- Change from Baseline in LDL Cholesterol(Baseline and day 112)
- Change from Baseline in Total Cholesterol(Baseline and day 112)
- Change from Baseline in Triglycerides(Baseline and day 112)
- Number of participants with anti drug antibodies (ADA) to efinopegdutide(At designated timepoints up to 112 days)