A Randomized, Open-label, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Tulisokibart Delivered by 2 Different Autoinjectors in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tulisokibart
研究概览
简要总结
The goal of this study is to learn what happens to MK-7240 in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of MK-7240 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 55 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:
- •Has a body-mass index (BMI) between 18 and 32 kg/m^2
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has a history of more than 1 episode of herpes zoster infection or history of disseminated herpes zoster infection
- •Has a history of or current active tuberculosis (TB) infection or history of latent TB that was not fully treated
研究组 & 干预措施
Arm 1: Tulisokibart Form 1
Participants will receive tulisokibart form 1.
干预措施: Tulisokibart Form 1 (Biological)
Arm 2: Tulisokibart Form 2
Participants will receive tulisokibart form 2.
干预措施: Tulisokibart Form 2 (Biological)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tulisokibart
时间窗: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the AUC0-inf of tulisokibart.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tulisokibart
时间窗: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the AUC0-last of tulisokibart.
Maximum Plasma Concentration (Cmax) of Tulisokibart
时间窗: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the Cmax of tulisokibart.
次要结局
- Number of Participants Who Discontinue Study Due to an AE(At designated timepoints up to 14 weeks)
- Time to Maximum Plasma Concentration (Tmax) of Tulisokibart(At designated timepoints up to 14 weeks)
- Apparent Clearance (CL/F) of Tulisokibart(At designated timepoints up to 14 weeks)
- Apparent Volume of Distribution (V/F) of Tulisokibart(At designated timepoints up to 14 weeks)
- Apparent Terminal Half-life (t1/2) of Tulisokibart(At designated timepoints up to 14 weeks)
- Apparent Terminal Elimination Rate constant (Kel) of Tulisokibart(At designated timepoints up to 14 weeks)
- Ratio of AUC0-Last/AUC0-Inf of Tulisokibart(At designated timepoints up to 14 weeks)
- Area Under the Concentration-Time Curve from Time 0 to Day 14 (pAUC0-14) of Tulisokibart(At designated timepoints up to 14 days)
- Number of Participants Who Experience an Adverse Event (AE)(At designated timepoints up to 14 weeks)