A Prospective Exploratory Study of the Safety and Preliminary Efficacy of the α-Syn H21 Monoclonal Antibody in Patients With Multiple System Atrophy
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 75 years old?
Source: NCT07774585, who can take part
Where in China
- Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025Shanghai, ChinaContact: Jun LIU, MD, PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT07774585
- Record updated
- 19 August 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Participation in another clinical trial or receipt of investigational treatment within 3 months before enrollment; 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; Any other condition that, in the investigator's judgment, would make participation inappropriate; Women or men unwilling to use effective contraception during the study.