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A Prospective Exploratory Study of the Safety and Preliminary Efficacy of the α-Syn H21 Monoclonal Antibody in Patients With Multiple System Atrophy

2026年8月17日 更新者：Ruijin Hospital

Multiple system atrophy (MSA) is a progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism, and cerebellar ataxia. Abnormal aggregation of alpha-synuclein is believed to play an important role in disease progression. The α-Syn H21 monoclonal antibody is designed to selectively bind pathological alpha-synuclein aggregates and may reduce their spread and related neuroinflammation.

This single-center, prospective, exploratory study will evaluate the safety, tolerability, and preliminary efficacy of the α-Syn H21 monoclonal antibody in patients with MSA. Participants will receive intravenous infusions of H21 every 4 weeks for 3 doses and will be followed for 12 weeks. Clinical symptoms, laboratory tests, imaging findings, and adverse events will be assessed to determine whether H21 may provide clinical benefit and support future larger studies.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

3

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200025
        • Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age 45 to 75 years, male or female
  • Diagnosis of Multiple System Atrophy meeting current clinical diagnostic criteria for probable or possible MSA
  • Disease duration of 2 years or less from onset of motor or autonomic symptoms
  • Clinically stable disease without significant fluctuation or acute worsening within 4 weeks before enrollment
  • Able to comply with study procedures and follow-up assessments
  • Mini-Mental State Examination (MMSE) score not consistent with significant dementia
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • History or presence of other neurological disorders that may interfere with study assessments, including Parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, or stroke
  • Severe cognitive impairment or psychiatric disorder, including clinically significant depression or anxiety
  • Severe cardiac, hepatic, renal, or other major systemic disease
  • History of severe hypersensitivity to monoclonal antibody therapies Pregnant or breastfeeding women
  • Women or men unwilling to use effective contraception during the study
  • Participation in another clinical trial or receipt of investigational treatment within 3 months before enrollment
  • Any other condition that, in the investigator's judgment, would make participation inappropriate

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：H21 Treatment
生物：α-Syn H21 Monoclonal Antibody
The α-Syn H21 monoclonal antibody is a humanized monoclonal antibody designed to selectively bind pathological alpha-synuclein aggregates. Participants will receive the study drug by intravenous infusion once every 4 weeks for a total of 3 doses during the 12-week study period.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of treatment-emergent adverse events
大体时间：From first dose through Week 12
Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) to study treatment.
From first dose through Week 12
Change from Baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) Total Score (Parts I-IV)
大体时间：Baseline, Week 4, Week 8, and Week 12
Change from baseline in the total score and subscale scores of the Unified Multiple System Atrophy Rating Scale (UMSARS Parts I-IV). The UMSARS is a clinician-administered scale used to assess disease severity in patients with multiple system atrophy. Total scores are derived from Parts I-IV, with higher scores indicating greater disease severity and worse clinical status. The total score ranges from 0 to 249, with higher scores indicating more severe impairment.
Baseline, Week 4, Week 8, and Week 12
Change from baseline in DAT-PET/MRI measures of striatal dopamine transporter uptake and brain structural changes
大体时间：Baseline and Week 12
Change from baseline in DAT-PET/MRI imaging parameters, including brain metabolic and structural changes.
Baseline and Week 12

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
大体时间：Baseline, Week 4, Week 8, and Week 12
Change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS Parts I-IV) total and subscale scores. The MDS-UPDRS is a clinician-administered scale used to assess the severity and progression of Parkinsonian symptoms. The total score ranges from 0 to 260, with higher scores indicating greater disease severity and worse motor and non-motor impairment.
Baseline, Week 4, Week 8, and Week 12
Change in Patient Global Impression of Improvement (PGI-I) Score
大体时间：Baseline, Week 4, Week 8, and Week 12
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure assessing overall perceived improvement following treatment. Scores range from 1 (very much improved) to 7 (very much worse), with lower scores indicating better perceived improvement.
Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Mini-Mental State Examination (MMSE) Score
大体时间：Baseline, Week 4, Week 8, and Week 12
Change from baseline in the Mini-Mental State Examination (MMSE) score. The MMSE is a widely used clinician-administered screening tool for global cognitive function, assessing domains including orientation, attention, memory, language, and visuospatial abilities. Scores range from 0 to 30, with higher scores indicating better cognitive function and lower scores indicating greater cognitive impairment.
Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Hamilton Depression Rating Scale (HAMD) Score
大体时间：Baseline, Week 4, Week 8, and Week 12
Change from baseline in the Hamilton Depression Rating Scale (HAMD) score. The HAMD is a clinician-administered scale used to assess the severity of depressive symptoms. Scores range from 0 to 52 (17-item version), with higher scores indicating more severe depressive symptoms and lower scores indicating less severe depression.
Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score
大体时间：Baseline, Week 4, Week 8, and Week 12
Change from baseline in the Hamilton Anxiety Rating Scale (HAMA) score. The HAMA is a clinician-administered scale used to assess the severity of anxiety symptoms. Scores range from 0 to 56, with higher scores indicating more severe anxiety symptoms and lower scores indicating less severe anxiety.
Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2) Score
大体时间：Baseline, Week 4, Week 8, and Week 12
Change from baseline in the Parkinson's Disease Sleep Scale-2 (PDSS-2) score. The PDSS-2 is a patient-reported scale used to assess the severity of nocturnal disturbances and sleep-related symptoms in patients with Parkinson's disease. Scores range from 0 to 60, with higher scores indicating more severe sleep disturbances and poorer sleep quality.
Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Score
大体时间：Baseline, Week 4, Week 8, and Week 12
Change from baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) score. The PDQ-39 is a patient-reported questionnaire used to assess health-related quality of life in patients with Parkinson's disease across eight domains, including mobility, activities of daily living, emotional well-being, and social support. Scores range from 0 to 156, with higher scores indicating poorer health-related quality of life and greater disease impact.
Baseline, Week 4, Week 8, and Week 12
Number of Participants With Clinically Significant Abnormal Laboratory Values
大体时间：Baseline, Week 4, Week 8, and Week 12
The number of participants with clinically significant abnormal laboratory values following H21 administration, including abnormalities in hematology, urinalysis, liver function, and renal function tests, as assessed by the investigator.
Baseline, Week 4, Week 8, and Week 12
Change from baseline in electrocardiogram parameters including heart rhythm, PR interval, QRS duration, and QTc interval
大体时间：Baseline, Week 4, Week 8, and Week 12
Standard 12-lead electrocardiograms will be performed at scheduled visits to assess changes from baseline in cardiac conduction and rhythm parameters, including heart rhythm, PR interval, QRS duration, and corrected QT (QTc) interval, following H21 administration.
Baseline, Week 4, Week 8, and Week 12
Change in Blood Pressure After Infusion
大体时间：Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Change in blood pressure measured before each H21 infusion and at 10 minutes and 30 minutes after infusion to evaluate short-term hemodynamic changes associated with study drug administration.
Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Change in Heart Rate After Infusion
大体时间：Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Change in heart rate measured before each H21 infusion and at 10 minutes and 30 minutes after infusion to evaluate short-term cardiac responses associated with study drug administration.
Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Change in Respiratory Rate After Infusion
大体时间：Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Change in respiratory rate measured before each H21 infusion and at 10 minutes and 30 minutes after infusion to evaluate short-term respiratory changes associated with study drug administration.
Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Serum Concentration of H21
大体时间：During treatment through Week 12
Serum concentrations of H21 will be measured at prespecified time points following administration to characterize the concentration-time profile of H21.
During treatment through Week 12
Maximum Observed Serum Concentration (Cmax) of H21
大体时间：During treatment through Week 12
The maximum observed serum concentration (Cmax) of H21 following administration.
During treatment through Week 12
Time to Maximum Observed Serum Concentration (Tmax) of H21
大体时间：During treatment through Week 12
The time to reach the maximum observed serum concentration (Tmax) of H21 following administration.
During treatment through Week 12
Area Under the Serum Concentration-Time Curve (AUC) of H21
大体时间：During treatment through Week 12
The area under the serum concentration-time curve (AUC) of H21 following administration.
During treatment through Week 12
Terminal Elimination Half-life (t1/2) of H21
大体时间：During treatment through Week 12
The terminal elimination half-life (t1/2) of H21 following administration.
During treatment through Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ruijin Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月15日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • H21-MSA

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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