A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB076 in Healthy Volunteers and Subjects With Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 46
- 试验地点
- 8
- 主要终点
- Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The primary objective of the study is to evaluate the safety and tolerability of single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and participants with Alzheimer's disease (AD). A secondary objective of the study for both healthy volunteers and participants with AD is to assess the serum pharmacokinetic(s) (PK) profile of BIIB076 after single-dose administration. Another secondary objective is to evaluate the immunogenicity of BIIB076 in serum after single-dose administration.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort HV1
干预措施: BIIB076 (Drug)
Cohort HV1
干预措施: Placebo (Drug)
Cohort HV2
干预措施: BIIB076 (Drug)
Cohort HV2
干预措施: Placebo (Drug)
Cohort HV3
干预措施: BIIB076 (Drug)
Cohort HV3
干预措施: Placebo (Drug)
Cohort HV4
干预措施: BIIB076 (Drug)
Cohort HV4
干预措施: Placebo (Drug)
Cohort HV5
干预措施: BIIB076 (Drug)
Cohort HV5
干预措施: Placebo (Drug)
Cohort AD1
干预措施: BIIB076 (Drug)
Cohort AD1
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to Week 20
Safety surveillance
次要结局
- BIIB076 serum pharmacokinetics (PK) concentration levels(Up to Week 20)
- PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf)(Up to Week 20)
- PK parameter of BIIB076: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)(Up to Week 20)
- PK parameter of BIIB076: Maximum observed concentration (Cmax)(Up to Week 20)
- PK parameter of BIIB076: Time to reach maximum observed concentration (Tmax)(Up to Week 20)
- PK parameter of BIIB076: Terminal elimination half-life (t1/2)(Up to Week 20)
- PK parameter of BIIB076: Clearance (CL)(Up to Week 20)
- PK parameter of BIIB076: Volume of distribution (Vd)(Up to Week 20)
- Number of participants with positive serum BIIB076 antibodies(Up to Week 20)