ClinicalTrials.gov record NCT07774585
A Prospective Exploratory Study of the Safety and Preliminary Efficacy of the α-Syn H21 Monoclonal Antibody in Patients With Multiple System Atrophy
A Prospective Exploratory Study of the Safety and Preliminary Efficacy of the α-Syn H21 Monoclonal Antibody in Patients With Multiple System Atrophy
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 1, single-group study will evaluate the safety, tolerability, and preliminary efficacy of the α‑Syn H21 monoclonal antibody in people with Multiple System Atrophy. Participants receive three intravenous infusions given every 4 weeks and are followed for a total of 12 weeks. Clinical assessments, imaging, lab tests, and monitoring for adverse events are used to collect study data.
What it is studying. The study is testing whether giving the α‑Syn H21 monoclonal antibody to people with Multiple System Atrophy is safe and tolerated, and whether there are any early signs of clinical or imaging changes. Study measurements named in the registry include adverse events and serious adverse events, clinical rating scales (UMSARS and MDS‑UPDRS), patient-reported improvement, cognitive and mood scales, DAT‑PET/MRI imaging, heart tests (ECG), vital signs around infusions, laboratory tests, and blood measurements of H21 levels.
What the researchers hope to learn. To evaluate the safety and tolerability of α‑Syn H21 in people with Multiple System Atrophy; to collect early data on clinical measures and imaging; and to characterize serum concentrations and basic pharmacokinetic parameters to inform future studies.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- α-Syn H21 Monoclonal Antibody
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will receive three intravenous infusions of the α-Syn H21 monoclonal antibody, given once every 4 weeks, and be followed for 12 weeks. Visits at baseline and Weeks 4, 8, and 12 will include clinician-rated scales and patient questionnaires to track symptoms and quality of life (UMSARS, MDS‑UPDRS, PGI‑I, MMSE, HAMD, HAMA, PDSS‑2, PDQ‑39). Imaging with DAT‑PET/MRI will be performed at baseline and Week 12; routine laboratory tests, ECGs, and vital-sign checks (including blood pressure, heart rate, and respiratory rate before and at 10 and 30 minutes after each infusion) will be done, and blood samples will be collected to measure H21 levels. Investigators will monitor and record adverse events and serious adverse events throughout the study.
How the study is structured. An interventional, Phase 1, single-group study with no masking. All participants receive the same study drug given by intravenous infusion once every 4 weeks for three doses across a 12‑week period. Assessments are scheduled at baseline and at Weeks 4, 8, and 12, with DAT‑PET/MRI imaging at baseline and Week 12; vital signs are recorded before and shortly after each infusion; blood samples are taken during treatment to measure H21 concentrations.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- Sep 15, 2026 (estimated)
- Primary completion
- Dec 31, 2026 (estimated)
- Study completion
- Dec 31, 2026 (estimated)
- Target enrollment
- 3 participants (estimated)
- Last updated on registry
- Aug 19, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Ruijin Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Jun Liu, MD, PhD 📞 021-86-64370045 ✉ jly0520@hotmail.com
- Yan SHEN, MD, PhD 📞 +86-021-64370045 ✉ shenyanzmins@sina.com
Participating sites (1)
- Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025
Shanghai, Shanghai Municipality, 200025 · China
- Jun LIU, MD, PhD · 86-021-64370045 · jly0520@hotmail.com
Terms used on this page · explanations by MedicalUpdates.ai
- adverse events
- Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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