A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear Palsy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 48
- 试验地点
- 13
- 主要终点
- Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of multiple ascending intravenous infusions of BMS-986168 and to assess the pharmacokinetics and immunogenicity of BIIB092, and pharmacodynamics of BIIB092 on cerebrospinal fluid (CSF) extracellular tau (eTau) concentrations in participants with Progressive Supranuclear Palsy.
详细描述
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.
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
- 41 Years 至 86 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
Panel 1: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
干预措施: BIIB092 (Drug)
Panel 1: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
干预措施: Placebo (Drug)
Panel 2: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
干预措施: BIIB092 (Drug)
Panel 2: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
干预措施: Placebo (Drug)
Panel 3: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
干预措施: BIIB092 (Drug)
Panel 3: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
干预措施: Placebo (Drug)
Panel 4: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
干预措施: BIIB092 (Drug)
Panel 4: BIIB092/ Placebo
BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Day 1 - Day 169
次要结局
- Time of Maximum Serum Concentration (Tmax)(Day 1 - Day 196)
- Immunogenicity of BIIB092 Measured by Presence or Absence of Anti-BIIB092 Antibodies in Serum(Day 1 - Day 169)
- Percent Change from Baseline in Extracellular Tau (eTau) Concentration in Cerebrospinal Fluid(Day 1 - Day 85)
- Maximum Serum Concentration (Cmax) of BIIB092(Day 1 - Day 196)
- Serum Concentration at 4 Weeks After Dosing of BIIB092(Day 1 - Day 196)
- Area Under the Concentration Time-curve of BIIB092 in One Dosing Interval (AUC(TAU))(Day 1 - Day 196)
- Trough Serum Concentration (Ctrough) of BIIB092(Day 1 - Day 196)