A Study on Pharmacokinetics of Remternetug Administered Subcutaneously Through an Autoinjector Versus Prefilled Syringe in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Pharmacokinetic (PK): Maximum Concentration (Cmax) of Remternetug
研究概览
简要总结
The main purpose of this study is to evaluate to different formulations of remternetug after single subcutaneous (SC) administration with either an autoinjector (AI) or a prefilled syringe (PFS). The study will look at the amount of remternetug that gets into the bloodstream and how long it takes the body to get rid of the remternetug when given as two different formulations.
Participation in the study will last approximately 155 days.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •Have a body mass index within the range of 18.0 to 34.0 kilograms per meter squared (kg/m2) (inclusive).
排除标准
- •Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs or of constituting a risk when taking the study drug or of interfering with the interpretation of data.
- •Have evidence of significant active neuropsychiatric disease, as determined by the investigator.
- •Have a personal or family history of early onset AD (AD diagnosed prior to 65 years of age).
- •Contraindication to MRI, including claustrophobia that cannot be managed with low-dose sedatives or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemakers.
- •Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, with the exception of vitamin/mineral supplements, any hormone replacement therapy, and/or thyroid replacement therapy, within 7 days prior to dosing and for the duration of the study.
- •Have a brain MRI that demonstrates any clinically significant findings that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study.
研究组 & 干预措施
Remternetug (Test)
Remternetug administered subcutaneously (SC) via autoinjector (AI)
干预措施: Remternetug (Test) (Drug)
Remternetug (Reference)
Remternetug administered SC via prefilled syringe.
干预措施: Remternetug (Reference) (Drug)
结局指标
主要结局
Pharmacokinetic (PK): Maximum Concentration (Cmax) of Remternetug
时间窗: Predose up to Day 85
Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve from Zero to time t [AUC(0-t)] of Remternetug
时间窗: Predose up to Day 85
Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity [AUC(0-inf)] of Remternetug
时间窗: Predose up to Day 85
次要结局
- Pharmacokinetic (PK): Time of Maximum Concentration (tmax) of Remternetug(Predose up to Day 85)