A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamic Response of Repeated Intravenous Infusions of BAN2401 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamic response of repeated intravenous infusions of BAN2401 in subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild Alzheimer's disease.
详细描述
This is a multicenter, randomized, placebo-controlled, double-blind, multiple ascending dose study in a total of 24 subjects (8 subjects per cohort) with MCI due to AD and mild AD. The study consists of three cohorts to evaluate the safety, tolerability and PK of BAN2401 at three dose levels (2.5, 5, and 10 mg/kg). Each cohort consists of Screening Period before randomization, Treatment Period from randomization to last dose, and Follow-up Period after last dose. Cohorts 1, 2, and 3 will receive 2.5 mg/kg, 5 mg/kg, and 10 mg/kg of BAN2401, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BAN2401 2.5 mg/kg
Cohorts 1: Intravenous infusions of 2.5 mg/kg BAN2401
干预措施: BAN2401 2.5 mg/kg (Drug)
BAN2401 5 mg/kg
Cohorts 2: Intravenous infusions of 5 mg/kg BAN2401
干预措施: BAN2401 5 mg/kg (Drug)
BAN2401 10 mg/kg
Cohorts 3: Intravenous infusions of 10 mg/kg BAN2401
干预措施: BAN2401 10 mg/kg (Drug)
Placebo
Intravenous infusions of placebo for 60 +/- 10 minutes.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to 14 weeks
Safety assessment variables will include all adverse events (AEs) including serious and non-serious AEs; laboratory parameters (hematology, blood chemistry, and urinalysis); vital signs; electrocardiograms; and physical examination; as well as a risk of suicide using C-SSRS and brain MRI.
次要结局
- Pharmacokinetics of BAN2401: Maximum Concentration (Cmax)(Up to 14 weeks)
- Pharmacokinetics of BAN2401: time attain to Cmax (tmax)(Up to 14 weeks)
- Pharmacokinetics of BAN2401: Area under the curve (AUC)(Up to 14 weeks)
- Pharmacokinetics of BAN2401: Drug Clearance (CL)(Up to 14 weeks)
- Pharmacokinetics of BAN2401: apparent volume of distribution at steady state (Vss)(Up to 14 weeks)
- Investigation of the effect of repeated intravenous infusions of BAN2401 on the immunogenicity and CSF biomarkers(Up to 14 weeks)
- Investigation of the effect of apolipoprotein allele4 (ApoE4) on the safety, tolerability and pharmacodynamic (PD) response of repeated intravenous infusions of BAN2401(Up to 14 weeks)