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

Sponsor
Ruijin Hospital
Study ID
NCT07774585
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Multiple System Atrophy

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • α-Syn H21 Monoclonal Antibody — BIOLOGICAL
    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 Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Sep 15, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
3 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: H21 Treatment

Primary Outcome Measure

Incidence of treatment-emergent adverse events [ Time Frame: From first dose through Week 12 ]

Central Contacts

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