An Open-Label, Parallel-Group, Randomized Study to Demonstrate the Bioequivalence of the Subcutaneous Formulation of Lecanemab Supplied in Vials and a Single-Use Auto-Injector
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Tmax: Time to Reach the Maximum (Peak) Serum Concentration for Lecanemab
研究概览
简要总结
The primary purpose of this study is to demonstrate the bioequivalence (BE) of a single subcutaneous (SC) dose of lecanemab via vial and AI in healthy participants.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoking, male or female, age greater than or equal to (>=) 18 years and less than or equal to (<=) 65 years at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing
- •Body Mass Index >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at Screening
排除标准
- •Clinically significant illness that requires medical treatment within 8 weeks of dosing or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- •Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
- •Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5 half-lives of the other investigational drug, whichever is longer, preceding informed consent
- •Prior exposure to lecanemab, or any other anti-amyloid therapies
- •Hypersensitivity to lecanemab or any of the excipients, or to any (monoclonal anti-body [mAb]) treatment
研究组 & 干预措施
Treatment B: Lecanemab 720 mg
Participants will receive a single SC dose of lecanemab 720 mg in the lower abdomen using AI on Day 1.
干预措施: Lecanemab (Drug)
Treatment A: Lecanemab 720 mg
Participants will receive a single SC dose of lecanemab 720 milligram (mg) in the lower abdomen using a vial and syringe on Day 1.
干预措施: Lecanemab (Drug)
结局指标
主要结局
Tmax: Time to Reach the Maximum (Peak) Serum Concentration for Lecanemab
时间窗: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
Cmax: Maximum Observed Serum Concentration for Lecanemab
时间窗: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab
时间窗: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab
时间窗: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
t1/2: Terminal Elimination Phase Half-life for Lecanemab
时间窗: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
次要结局
- Number of Participants With Abnormal Laboratory Values(Baseline up to Day 22)
- Number of Participants With Abnormal Vital Signs Values(Baseline up to Day 50)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to Day 50)
- Number of Participants With Anti-drug Antibodies (ADAs)(Baseline up to Day 50)
- Number of Participants With Neutralizing Antibodies (NAbs)(Baseline up to Day 50)