A Single Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion and Intravenous Bolus Administration of MK-2060 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Number of Participants With An Adverse Event (AE)
研究概览
简要总结
The goal of the study is to learn about the safety of MK-2060 and if people tolerate it when MK-2060 is given in different forms.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 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) between ≥18 and ≤32 kg/m^2, inclusive
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
- •Has a history of cancer
研究组 & 干预措施
Panel A: MK-2060 IV (20 minutes)
Participants will receive a single dose of MK-2060 via intravenous (IV) infusion over 20 minutes on Day 1.
干预措施: MK-2060 (Biological)
Panel B: MK-2060 IV (10 minutes)
Participants will receive a single dose of MK-2060 via IV infusion over 10 minutes on Day 1.
干预措施: MK-2060 (Biological)
Panel C: MK-2060 IV (5 minutes)
Participants will receive a single dose of MK-2060 via syringe over 5 minutes on Day 1.
干预措施: MK-2060 (Biological)
Panel D: MK-2060 IV (2.5 minutes)
Participants will receive a single dose of MK-2060 via syringe over 2.5 minutes on Day 1.
干预措施: MK-2060 (Biological)
Panel E: MK-2060 IV (1 minute)
Participants will receive a single dose of MK-2060 via syringe over 1 minute on Day 1.
干预措施: MK-2060 (Biological)
Placebo
Participants will receive a single dose of saline via IV infusion or syringe over MK-2060-matched time period on Day 1.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Participants With An Adverse Event (AE)
时间窗: Up to 134 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants that experience an AE will be reported.
Number of Participants Discontinuing the Study Due to an AE
时间窗: Up to 134 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants that discontinue the study due to an AE will be reported.
次要结局
- Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC0-inf)(Predose and at designated time points post dose up to 120 days)
- Maximum Observed Plasma Concentration (Cmax) of MK-2060(Predose and at designated time points post dose up to 120 days)
- Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours (AUC0-168)(Predose and at designated time points post dose up to 120 days)
- Plasma Concentration of MK-2060 at 168 Hours (C168)(Predose and at designated time points post dose up to 120 days)
- Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060(Predose and at designated time points post dose up to 120 days)
- Plasma Elimination Terminal Half-life (t ½) of MK-2060(Predose and at designated time points post dose up to 120 days)
- Apparent Oral Clearance (CL/F) of MK-2060(Predose and at designated time points post dose up to 120 days)
- Plasma Apparent Volume of Distribution (Vz/F) of MK-2060(Predose and at designated time points post dose up to 120 days)
- Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060(Baseline and up to 120 days)