Loading clinical trials...

RECRUITINGPHASE2

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

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

NCT06848231•Yoda Therapeutics Inc.

View on ClinicalTrials.gov

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.

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

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (9)

UCLA Health

Los Angeles, California, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Columbia University Irving medical center

New York, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

Juntendo University Hospital

Tokyo, Japan

National Taiwan University Hospital

Taipei, Taiwan

National Taiwan University Hospital Cancer Center

Taipei, Taiwan

Key Dates

Start Date

March 3, 2025

Primary Completion Date

June 30, 2026

Completion Date

December 31, 2026

Last Updated

September 10, 2025

Enrollment

ESTIMATED participants

Conditions

Multiple System Atrophy

Interventions

YA-101

DRUG

Placebo

DRUG

Contacts

Email contact via Yoda Therapeutics Inc.

CONTACT

857-468-9328 info@yodapharma.com

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

View study

RECRUITINGPHASE1

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

NCT02429557

Orthostatic HypotensionPure Autonomic Failure+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

PET Imaging Evaluation of [11C]SY08

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ION464 Administered to Adults With Multiple System Atrophy (HORIZON)

Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure

Insulin Resistance in Multiple System Atrophy