A Multiple Ascending Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-2225 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
The purpose of the study is to learn about the safety of MK-2225, including how well people tolerate it. Researchers also want to learn what happens to different doses of MK-2225 in a person's body over time.
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
- Double (Participant, Investigator)
盲法说明
Double blinded
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
- •The key inclusion criteria include but are not limited to the following:
- •Is in good health before randomization
- •Body Mass Index (BMI) ≤32 kg/m^2, inclusive
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •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
- •History of hypersensitivity to the MK-2225 drug substance, its inactive ingredients or the placebo (normal saline)
研究组 & 干预措施
MK-2225 Panel A
Participants receive MK-2225 Dose 1 subcutaneously (SQ) once every 2 weeks (Q2W) over the course of 8 weeks.
干预措施: MK-2225 (Drug)
MK-2225 Panel B
Participants receive MK-2225 Dose 2 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.
干预措施: MK-2225 (Drug)
MK-2225 Panel C
Participants receive MK-2225 Dose 3 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.
干预措施: MK-2225 (Drug)
MK-2225 Panel D
Participants receive MK-2225 Dose 4 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.
干预措施: MK-2225 (Drug)
Placebo
Participants receive placebo SQ Q2W over the MK-2225-matched time period.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 20 weeks
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 8 weeks
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/study treatment due to an AE will be reported.
次要结局
- Maximum Plasma Concentration (Cmax) of MK-2225(At designated timepoints (up to approximately 16 weeks))
- Lowest Plasma Concentration (Ctrough) of MK-2225(At designated timepoints (up to approximately 16 weeks))
- Time to Maximum Plasma Concentration (Tmax) of MK-2225(At designated timepoints (up to approximately 16 weeks))
- Area Under the Concentration-Time Curve from Time 0 to Tau (AUC0-τ) of MK-2225(At designated timepoints (up to 16 approximately weeks))
- Apparent Terminal Half-life (t1/2) of MK-2225(At designated timepoints (up to approximately 16 weeks))
- Mean Accumulation Ratio of MK-2225(At designated timepoints (up to approximately 16 weeks))