A Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of a range of single and 13 repeated doses of BIIB054, administered as intravenous (IV) infusion, in Japanese participants with Parkinson's disease (PD). The secondary objectives are to evaluate the immunogenicity, and serum pharmacokinetics (PK) profile of BIIB054 after single and multiple dose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 否
入选标准
- •Diagnosed with PD within a maximum of 3 years prior to screening.
- •Has not received levodopa or any other treatment for PD, herein referred to as symptomatic PD medication (including but, not limited to, dopamine agonists, amantadine, anticholinergics, monoamine oxidase type B (MAO-B) inhibitors, or safinamide) for at least 12 weeks prior to Day
- •Maximum total duration of prior PD regimens should not exceed 30 days.
- •Score of less than equal to (<=) 2.5 on the Modified Hoehn and Yahr Scale.
- •Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reader).
排除标准
- •Presence of freezing of gait.
- •History of or positive test result at Screening for human immunodeficiency virus (HIV) or hepatitis C virus antibody (anti-HCV).
- •Screening value for hemoglobin less than (<)12 gram per deciliter (g/dL) for men or <11 g/dL for women.
- •Montreal Cognitive Assessment (MoCA) score <23 or other significant cognitive impairment or clinical dementia.
- •History of any brain surgery for PD.
- •Participation in any passive or active immunotherapy targeting alpha-synuclein or other PD-related protein.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cohort 1: BIIB054 Dose A
Participants will receive IV infusion of BIIB054 Dose A (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
干预措施: BIIB054 (Drug)
Cohort 2: BIIB054 Dose B
Participants will receive IV infusion of BIIB054 Dose B (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
干预措施: BIIB054 (Drug)
Cohort 3: BIIB054 Dose C
Participants will receive IV infusion of BIIB054 Dose C (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
干预措施: BIIB054 (Drug)
Cohorts 1-3: Placebo
Participants will receive a single IV infusion of BIIB054 matching placebo (single infusion on Day 1 followed by an observation period; with subsequent doses for 48 weeks)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to 72 Weeks
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, or is a medically important event.
次要结局
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054(Up to 24 Weeks)
- Time to Reach Maximum Observed Serum Concentration (Tmax) of BIIB054(Up to 24 Weeks)
- Terminal Elimination Half-life (t1/2) of BIIB054(Up to 24 Weeks)
- Number of Participants With Anti-BIIB054 Antibodies in Serum(Up to 72 Weeks)
- Clearance (CL) of BIIB054(Up to 24 Weeks)
- Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054(Up to 24 Weeks)
- Maximum Observed Serum Concentration (Cmax) of BIIB054(Up to 24 Weeks)
- Accumulation Ratio of BIIB054(Up to 24 Weeks)
- Observed Concentration at the End of Dosing Interval (Ctrough) of BIIB054(Up to 24 Weeks)
- Volume of Distribution at Steady State (Vss) of BIIB054(Up to 24 Weeks)