A Randomized, Open Label, Parallel Group Phase 1 Study to Compare Safety, Tolerability and Pharmacokinetics of Subcutaneously Administered MK-1406 as Three Injections Compared With Two Injections in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Part 1: Area Under the Concentration Time Curve From Time 0 to 4 Weeks (AUC0-4w) of MK-1406
研究概览
简要总结
The purpose of this trial is to compare what happens to MK-1406 in the body of healthy participants when it is given as 2-injections and 3-injections. Researchers also want to learn about the safety of MK-1406 and if people tolerate it.
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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Is in good health
- •Has body mass index (BMI) 18.0 to 32.0 kg/m^2
排除标准
- •The main 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 cancer (malignancy)
结局指标
主要结局
Part 1: Area Under the Concentration Time Curve From Time 0 to 4 Weeks (AUC0-4w) of MK-1406
时间窗: Predose and at designated timepoints up to 4 weeks postdose
Blood samples will be collected at pre-specified timepoints to determine the AUC0-4w of MK-1406.
Part 1 and Part 2: Number of Participants Who Experience One or More Adverse Events (AEs)
时间窗: Up to approximately 43 days postdose
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Part 1 and Part 2: Number of Participants Who Experience At Least One Solicited Injection-Site Reaction
时间窗: Up to approximately 7 days postdose
Solicited injection-site reactions include tenderness, pain, redness/erythema, and swelling. Participants will record injection site reactions using a paper diary. The number of participants with solicited injection-site reactions will be reported.
Part 1 and Part 2: Number of Participants Who Discontinue Study Due to an AE
时间窗: Up to approximately 43 days postdose
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 due to an AE will be reported.
次要结局
- Part 1: Maximum Plasma Concentration (Cmax) of MK-1406(Predose and at designated timepoints up to 4 weeks postdose)
- Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-1406(Predose and at designated timepoints up to 4 weeks postdose)
- Part 1: Plasma Concentration of MK-1406 at 4 Weeks (C4w)(Predose and at designated timepoints up to 4 weeks postdose)