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
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
UCLA Health
RECRUITING
Los Angeles
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Minnesota
Mayo Clinic
RECRUITING
Rochester
New York
Columbia University Irving medical center
RECRUITING
New York
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Baylor College of Medicine
RECRUITING
Houston
Other Locations
Japan
Juntendo University Hospital
RECRUITING
Tokyo
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
National Taiwan University Hospital Cancer Center
NOT_YET_RECRUITING
Taipei
Contact Information
Primary
Email contact via Yoda Therapeutics Inc.
info@yodapharma.com
857-468-9328
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 75
Treatments
Experimental: YA-101
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Yoda Therapeutics Inc.