An Open-label, Parallel-group, Randomized Study to Evaluate the Absolute Bioavailability of Single Dose Subcutaneous Administration of Lecanemab in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab
研究概览
简要总结
The primary purpose of this study is to determine the absolute bioavailability and pharmacokinetic (PK) profile of a single dose of lecanemab when administered subcutaneously (SC) 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
- •Participants must meet all of the following criteria to be included in this study:
- •Non-smoking, male or female, age greater than or equal to (>=) 18 years and less than or equal to (<=) 65 years old at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing.
- •Japanese participants (age >=20 years) must have been born in Japan of Japanese parents and Japanese grandparents, must have lived no more than 5 years outside of Japan, and must not have changed their lifestyle or habits, including diet, while living outside of Japan.
- •Body Mass Index (BMI) >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at screening.
排除标准
- •Participants who meet any of the following criteria will be excluded from this study:
- •Clinically significant illness that requires medical treatment within 8 weeks 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 subjects who have a congenital abnormality in metabolism
- •Exposure within the last 14 days before dosing to an individual with confirmed or probable corona virus disease-2019 (COVID-19) or symptoms within the last 14 days that are on the most recent Centers for Disease Control and Prevention list of COVID symptoms or any other reason to consider the participant at potential risk for COVID-19 infection
- •Participants who had received COVID vaccine but are not 14 days post full vaccination before dosing
- •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
- •Hypersensitivity to lecanemab or any of the excipients, or to any monoclonal antibody treatment
- •NOTE-Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Lecanemab 10 mg/kg
Participants will receive lecanemab 10 milligram per kilogram (mg/kg), as single dose IV infusion over approximately 1 hour on Day 1.
干预措施: Lecanemab (Drug)
Lecanemab 700 mg
Participants will receive lecanemab 700 milligram (mg), as single fixed dose SC injection in the abdomen on Day 1.
干预措施: Lecanemab (Drug)
结局指标
主要结局
AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab
时间窗: Days 0-50
AUC(0-72h): Area Under the Serum Concentration-time Curve From Time Zero to 72 Hours Post End of Intravenous (IV) Infusion or SC Administration for Lecanemab
时间窗: 0-72 hours
Cmax: Maximum Observed Serum Concentration for Lecanemab
时间窗: Days 0-50
Tmax: Time to Reach Maximum Serum Concentration for Lecanemab
时间窗: Days 0-50
T1/2: Terminal Elimination Half-life for Lecanemab
时间窗: Days 0-50
F: Absolute Bioavailability of SC Formulation for Lecanemab
时间窗: Days 0-50
Absolute bioavailability (F) = \[AUC(0-inf) SC\*Dose (IV)\]/\[AUC(0-inf) IV\*Dose (SC)\]. IV dose will be based on total dose (mg) infused.
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab
时间窗: Days 0-50
次要结局
- Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)(Baseline up to Day 50)
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values(Baseline up to Day 50)
- Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings(Baseline up to Day 50)
- Number of Participants With Positive and Negative Anti-drug Antibody (ADA) for Lecanemab(Baseline Up to Day 50)
- Number of Participants With Neutralizing Antibodies (NAb) for Lecanemab(Baseline up to Day 50)
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters(Baseline up to Day 22)