Overview
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
Inclusion Criteria:
- Able to understand the process of the clinical trial and give informed consent for the participation of the study.
- Diagnosis of MSA according to MDS clinical criteria (Wenning et al, 2022), including subjects with MSA of either subtype (MSA-P or MSA-C).
- Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception.
- Able to take oral medications.
- Able to ambulate without the assistance of another person.
Exclusion Criteria:
- Positive urine test for drugs of abuse and/or alcohol test both at screening and Day 1.
- Evidence of renal impairment or hepatic impairment.
- Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower.
- 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.
- Positive results for active viral infections, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.