Multiple System AtrophyPhase 1NCT07774585
A Prospective Exploratory Study of the Safety and Preliminary Efficacy of the α-Syn H21 Monoclonal Antibody in Patients With Multiple System Atrophy
A Phase 1 study testing α-Syn H21 Monoclonal Antibody in people with Multiple System Atrophy, run by Ruijin Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- α-Syn H21 Monoclonal Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025
Shanghai, Shanghai Municipality, 200025
Jun LIU, MD, PhD, 86-021-64370045, jly0520@hotmail.com
About this study
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.
- Conditions
- Multiple System Atrophy
- Being tested
- α-Syn H21 Monoclonal Antibody
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
α-Syn H21 Monoclonal AntibodyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| H21 Treatment | Experimental | Not described Receives: Biological: α-Syn H21 Monoclonal Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) to study treatment.
Measured: From first dose through Week 12
Change from Baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) Total Score (Parts I-IV)
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.
Measured: 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
Change from baseline in DAT-PET/MRI imaging parameters, including brain metabolic and structural changes.
Measured: Baseline and Week 12
Secondary outcomes (17)
Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Patient Global Impression of Improvement (PGI-I) Score
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Mini-Mental State Examination (MMSE) Score
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Hamilton Depression Rating Scale (HAMD) Score
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2) Score
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Score
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Number of Participants With Clinically Significant Abnormal Laboratory Values
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Change from baseline in electrocardiogram parameters including heart rhythm, PR interval, QRS duration, and QTc interval
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Blood Pressure After Infusion
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.
Measured: Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Change in Heart Rate After Infusion
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.
Measured: Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Change in Respiratory Rate After Infusion
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.
Measured: Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Serum Concentration of H21
Serum concentrations of H21 will be measured at prespecified time points following administration to characterize the concentration-time profile of H21.
Measured: During treatment through Week 12
Maximum Observed Serum Concentration (Cmax) of H21
The maximum observed serum concentration (Cmax) of H21 following administration.
Measured: During treatment through Week 12
Time to Maximum Observed Serum Concentration (Tmax) of H21
The time to reach the maximum observed serum concentration (Tmax) of H21 following administration.
Measured: During treatment through Week 12
Area Under the Serum Concentration-Time Curve (AUC) of H21
The area under the serum concentration-time curve (AUC) of H21 following administration.
Measured: During treatment through Week 12
Terminal Elimination Half-life (t1/2) of H21
The terminal elimination half-life (t1/2) of H21 following administration.
Measured: During treatment through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774585
- Sponsor's protocol ID
- H21-MSA
- Status last verified
- Apr 2026
- First submitted
- 12 May 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Exploratory Study of the Safety and Preliminary Efficacy of the α-Syn H21 Monoclonal Antibody in Patients With Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT07774585
- Acronym / sponsor ID
- H21-MSA
- Conditions
- Multiple System Atrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H21 Treatment | Experimental | Biological: α-Syn H21 Monoclonal Antibody |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| α-Syn H21 Monoclonal AntibodyThe 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. | Biological | H21 Treatment |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: From first dose through Week 12
Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) to study treatment.
Change from Baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) Total Score (Parts I-IV)
Time frame: 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.
Change from baseline in DAT-PET/MRI measures of striatal dopamine transporter uptake and brain structural changes
Time frame: Baseline and Week 12
Change from baseline in DAT-PET/MRI imaging parameters, including brain metabolic and structural changes.
17 secondary outcomes
Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Patient Global Impression of Improvement (PGI-I) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Mini-Mental State Examination (MMSE) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Hamilton Depression Rating Scale (HAMD) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Number of Participants With Clinically Significant Abnormal Laboratory Values
Time frame: Baseline, Week 4, Week 8, and Week 12
Change from baseline in electrocardiogram parameters including heart rhythm, PR interval, QRS duration, and QTc interval
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Blood Pressure After Infusion
Time frame: Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Change in Heart Rate After Infusion
Time frame: Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Change in Respiratory Rate After Infusion
Time frame: Pre-dose and 10 minutes and 30 minutes after each infusion through Week 12
Serum Concentration of H21
Time frame: During treatment through Week 12
Maximum Observed Serum Concentration (Cmax) of H21
Time frame: During treatment through Week 12
Time to Maximum Observed Serum Concentration (Tmax) of H21
Time frame: During treatment through Week 12
Area Under the Serum Concentration-Time Curve (AUC) of H21
Time frame: During treatment through Week 12
Terminal Elimination Half-life (t1/2) of H21
Time frame: During treatment through Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing α-Syn H21 Monoclonal Antibody in people with Multiple System Atrophy, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Liu, MD, PhD (021-86-64370045, jly0520@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: From first dose through Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.