Status:

RECRUITING

A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy

Lead Sponsor:

Dasher Neuroscience Inc.

Conditions:

Multiple System Atrophy

Eligibility:

All Genders

30+ years

Phase:

PHASE2

Brief Summary

This is a Phase 2, double-blind, placebo-controlled, multi-center, Phase II, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of Ya-101 in subjects with multip...

Detailed Description

The purpose of the study is to evaluate 2 doses of YA-101 compared to placebo in MSA patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) potential efficacy of YA-101.

Eligibility Criteria

Inclusion Criteria:

  1. Able to understand the process of the clinical trial and give informed consent for the participation of the study.
  2. Diagnosis of MSA according to MDS clinical criteria (Wenning et al, 2022), including subjects with MSA of either subtype (MSA-P or MSA-C).
  3. Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception.
  4. Able to take oral medications.
  5. Able to ambulate without the assistance of another person.

Exclusion Criteria:

  1. Positive urine test for drugs of abuse and/or alcohol test both at screening and Day 1.
  2. Evidence of renal impairment or hepatic impairment.
  3. Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower.
  4. Medical history includes severe systemic diseases such as cardiopulmonary failure, severe liver or kidney disease, and uncontrolled diabetes; significant central nervous system disorders like stroke, encephalitis, and epilepsy and severe head trauma; peptic ulcer in one year prior to screening.
  5. Positive results for active viral infections, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.

Key Trial Info

Start Date :

March 3 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT06848231

Start Date

March 3 2025

End Date

December 31 2026

Last Update

September 10 2025

Active Locations (9)

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Page 1 of 3 (9 locations)

1

UCLA Health

Los Angeles, California, United States, 90095

2

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

3

Mayo Clinic

Rochester, Minnesota, United States, 55905

4

Columbia University Irving medical center

New York, New York, United States, 10032