A 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 Multiple System Atrophy
Dasher Neuroscience Inc.
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 multiple system atrophy.
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
- Age range
- 30+ years
- Sex
- All
- Healthy volunteers
- No
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 screenin…
Interventions
- DrugYA-101
Drug: YA-101 • YA-101 taken BID
- DrugPlacebo
Placebo taken BID
Locations (9)
- UCLA HealthLos Angeles, California
- Brigham and Women's HospitalBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- Columbia University Irving medical centerNew York, New York
- Vanderbilt University Medical CenterNashville, Tennessee
- Baylor College of MedicineHouston, Texas