CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Not Yet Recruiting· 60 target
Drug / intervention
ALT001drug
Likely dose
ALT001 130 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT07476352
NCT07476352Early Ph 1Not Yet Recruiting
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Expansion Study of ALT001 in Patients With Multiple System Atrophy

yilong Wang·interventional·Posted Mar 17, 2026·Updated Mar 30, 2026

In Brief

A Early Phase 1 clinical trial evaluating ALT001 for Multiple System Atrophy. Not yet recruiting, targeting 60 participants across 1 site.

Detailed Summary

This is an open-label, single-center, prospective, single-arm clinical study. The primary objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of ALT001 in the treatment of patients with multiple system atrophy (MSA) in a real-world setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple System Atrophy
CountriesChina
Collaborators--

Timeline

Early Ph 1Not Yet Recruiting
2027
First PostedMar 17, 2026
Enrollment StartMay 6, 2026
Primary CompletionOct 30, 2027
TodayJul 1, 2026
Enrollment to primary: 1.5 yearsPosted 3 months agoPrimary completion in 1.3 years

Interventions

ALT001drug

"ALT001" is a nerve repair protein developed by Darwin Start (Hubei) Biopharmaceutical Co., Ltd. It is a group of specific microenvironmental protein polymers secreted under the emergency conditions of stem cells. It has the advantages of selective assembly, targeted delivery, efficient repair of damaged tissues, high safety, chemical stability, easy storage, etc., and has a powerful neural repair function. According to the groups, patients would be treated with ALT001 via intrathecal injection or intravenous injection. Intravenous administration of ALT001 was given to each MSA patient in the intervention group, with intravenous administration on days 1 to 14, 31 to 44±3 and 61 to 74±5, and treatment was given once a day. Intravenous administration: ALT001 (130 μg/branch) was dissolved in 100 ml sodium chloride injection, which was completed in about 30-40 minutes.