A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB054 in Healthy Subjects and Subjects With Early Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Columbia Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
The primary objective of the study is to evaluate the safety and tolerability of a range of single BIIB054 doses, administered as a single intravenous (IV) infusion, in healthy participants and participants with early Parkinson's disease (PD). Secondary objectives of the study are to assess the serum pharmacokinetics (PK) profile of BIIB054 after single-dose administration and to evaluate the immunogenicity of BIIB054 after single-dose administration.
详细描述
Only healthy participants will be enrolled in Cohorts 1 through 6. Only participants with early PD will be enrolled in Cohort 7
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All women of childbearing potential and all men must practice effective contraception during the study and for 6 months after their last dose of study treatment.
- •Must have a body mass index from 19 to 32 kg/m2, inclusive.
- •Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG.
- •For cohort 7 only:
- •Diagnosis of idiopathic PD
排除标准
- •History of cardiovascular disease.
- •Subject smokes more than 5 cigarettes or the equivalent in tobacco daily.
- •Surgery within 3 months prior to Day -1 (other than minor cosmetic surgery and minor dental surgery, as determined by the Investigator).
- •History or positive test result for hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).
- •Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cohort 7
Single IV ascending dose infusion with staggered participant dosing
干预措施: BIIB054 (Drug)
Cohort 1
Single intravenous (IV) low dose infusion with staggered participant dosing
干预措施: BIIB054 (Drug)
Cohort 1
Single intravenous (IV) low dose infusion with staggered participant dosing
干预措施: Placebo (Drug)
Cohort 2
Single IV ascending dose infusion with staggered participant dosing
干预措施: BIIB054 (Drug)
Cohort 2
Single IV ascending dose infusion with staggered participant dosing
干预措施: Placebo (Drug)
Cohort 3
Single IV ascending dose infusion with staggered participant dosing
干预措施: BIIB054 (Drug)
Cohort 3
Single IV ascending dose infusion with staggered participant dosing
干预措施: Placebo (Drug)
Cohort 4
Single IV ascending dose infusion with staggered participant dosing
干预措施: BIIB054 (Drug)
Cohort 4
Single IV ascending dose infusion with staggered participant dosing
干预措施: Placebo (Drug)
Cohort 5
Single IV ascending dose infusion with staggered participant dosing
干预措施: BIIB054 (Drug)
Cohort 5
Single IV ascending dose infusion with staggered participant dosing
干预措施: Placebo (Drug)
Cohort 6
Single IV ascending dose infusion with staggered participant dosing
干预措施: BIIB054 (Drug)
Cohort 6
Single IV ascending dose infusion with staggered participant dosing
干预措施: Placebo (Drug)
Cohort 7
Single IV ascending dose infusion with staggered participant dosing
干预措施: Placebo (Drug)
结局指标
主要结局
Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: 20 Weeks
The Columbia Suicide Severity Rating Scale, or C-SSRS, is a suicidal ideation rating scale created by researchers at Columbia University to evaluate suicidality.
Montreal Cognitive Assessment (MoCA)
时间窗: 20 Weeks
The Montreal Cognitive Assessment MoCA is a brief cognitive screening tool for Mild Cognitive Impairment.
Adverse events/serious adverse events (AEs/SAEs),
时间窗: 20 Weeks
After a range of single BIIB054 doses administered as a single IV infusion in healthy participants and participants with early Parkinson's Disease, clinical laboratory test data, vital signs, neurological and physical examination findings, 12-lead electrocardiogram (ECG) data, and brain magnetic resonance imaging (MRI) findings will be used in the evaluation of AEs/SAEs.
次要结局
- Evaluate serum BIIB054 concentrations and PK parameters(20 Weeks)
- evaluation of anti-BIIB054 antibodies in serum(20 Weeks)