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NOT YET RECRUITING
NCT07514923
EARLY_PHASE1

The Study of Safety and Preliminary Efficacy of ALT001 in Patients With MultIple System Atrophy-Cerebellar Type

Sponsor: yilong Wang

View on ClinicalTrials.gov

Summary

This is a single-center, prospective, randomized, open-label, blinded outcome assessment (PROBE) study. At the end of the PROBE study, patients who have completed the study may opt to enter the open-label extension (OLE) study. The objective of the study is to evaluate the safety, tolerability and potential preliminary efficacy of ALT001 in the treatment of patients with multiple system atrophy-cerebellar type (MSA-C).

Key Details

Gender

All

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-04-06

Completion Date

2027-10-30

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

ALT001

Intrathecal administration combined with intravenous administration of ALT001 was given to each MSA patient in the intervention group, with intrathecal administration on days 1, 31 and 61 and intravenous administration on days 2 to 14, 32 to 44±3 and 62 to 74±5, and treatment was given once a day. intrathecal administration: 8 mL sodium chloride injection + ALT001 (130 μg/branch) for intrathecal administration, which was completed in about 5 minutes; intravenous administration: ALT001 (130 μg/branch) was dissolved in 100 ml sodium chloride injection, which was completed in about 30-40 minutes. After completion of the above treatments and 90±7 days of follow-up, all subjects entered the OLE study phase. During this period, all participants were given the option of continuing to receive 3 phases (on Days 91 to 104±7, Days 121 to 134±7, and Days 151 to 164±7) of intravenous ALT001 administration (14 consecutive days of ALT001 130 μg qd i.v. in each phase).

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China