YA-101 for Multiple System Atrophy

Recruiting at 8 trial locations

Overseen By Email contact via Yoda Therapeutics Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yoda Therapeutics Inc.

Disqualifiers: Renal impairment, Hepatic impairment, Uncontrolled diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called YA-101, a potential drug for multiple system atrophy (MSA), a rare disorder affecting movement and other body functions. The study will assess the safety and effectiveness of YA-101 by comparing it to a placebo, a harmless pill with no active medicine. Participants must have an MSA diagnosis, be able to take pills orally, and walk without assistance. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to early-stage findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that YA-101 is likely to be safe for humans?

Research has shown that YA-101 has been tested for safety and tolerability. In earlier studies with healthy volunteers, YA-101 was generally well-tolerated even at higher doses. These studies aimed to understand the drug's metabolism and safety profile.

While detailed safety information for YA-101 in patients with multiple system atrophy (MSA) is not yet available, its progression to this research stage suggests some confidence in its safety. Treatments typically advance to this phase when early tests indicate they are safe enough for larger group studies.

Overall, researchers are closely monitoring YA-101 for any side effects or adverse reactions. Participants receive careful observation to ensure the treatment remains safe as more data is collected. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Multiple System Atrophy, which often focus on managing symptoms through medications like levodopa or fludrocortisone, YA-101 is unique because it targets the disease's progression at a cellular level. Researchers are excited about YA-101 because it utilizes a novel mechanism of action that aims to protect nerve cells from degeneration, potentially slowing down the disease's progression. This approach could offer a significant advantage over current options, which mainly provide symptomatic relief without altering the disease's course.

What evidence suggests that YA-101 might be an effective treatment for multiple system atrophy?

Research has shown that YA-101, which participants in this trial may receive, might help treat multiple system atrophy by affecting two important processes in the body. It blocks D-amino acid oxidase (DAAO) and the NLRP3 inflammasome, both of which contribute to inflammation and nerve damage. Early tests with healthy volunteers showed that YA-101 is safe and well-tolerated. Its movement through the body is promising, suggesting it could reach effective levels. Although more studies with patients are necessary, these early results offer hope for its potential in managing multiple system atrophy. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with multiple system atrophy, a progressive neurological disorder. Participants should meet specific health criteria set by the study and not have conditions that could interfere with the trial.

Inclusion Criteria

I can take pills by mouth.

I understand the clinical trial process and can consent to participate.

I have been diagnosed with MSA according to specific clinical criteria.

Exclusion Criteria

I have kidney or liver problems.

Positive urine test for drugs of abuse and/or alcohol test both at screening and Day 1

Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive YA-101 or placebo to evaluate safety, tolerability, pharmacokinetics, and efficacy

8 weeks

Regular visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• YA-101

Trial Overview The study tests YA-101 against a placebo to see if it's safe and effective for treating multiple system atrophy. It's double-blind, meaning neither participants nor researchers know who gets the real drug or placebo.

How Is the Trial Designed?

Group I: YA-101 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Yoda Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

40+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06848231

NCT06848231 | A Phase 2 Study of YA-101 in Patients ... This is a Phase 2, double-blind, placebo-controlled, multi-center, Phase II, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and ...

2. uclahealth.org uclahealth.org/clinical-trials/phase-2-study-ya-101-patients-with-multiple-system-atrophy

A Phase 2 Study of YA-101 in Patients With Multiple ... This is a Phase 2, double-blind, placebo-controlled, multi-center, Phase II, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/578935

A Phase 2 Study of YA-101 in Patients With Multiple System ... This is a Phase 2, double-blind, placebo-controlled, multi-center, Phase II, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and ...

4. biospace.com biospace.com/press-releases/yoda-therapeutics-announces-first-patient-dosed-in-phase-2-trial-of-ya-101-for-multiple-system-atrophy

Yoda Therapeutics Announces First Patient Dosed in ... This Phase 2 trial is a randomized, double-blind, placebo-controlled investigation for MSA patients with walking ability, including those who need walking ...

5. mdsabstracts.org mdsabstracts.org/abstract/pharmacokinetics-and-safety-of-ya-101-a-dual-inhibitors-of-d-amino-acid-oxidase-daao-and-nlrp3-inflammasome-in-healthy-subjects-a-double-blind-placebo-controlled-randomized-single-dose-and-mul/

Pharmacokinetics And Safety Of YA-101, A Dual Inhibitors ... Objective: To evaluate the safety, tolerability, and pharmacokinetics (PK) profile of YA-101 in healthy volunteers with single dose and multiple dose.

6. mayo.edu mayo.edu/research/clinical-trials/cls-20580643

YA-101 in Subjects with Multiple System Atrophy The purpose of this study is to evaluate the safety and tolerability of YA-101. Participation eligibility. Participant eligibility includes ...

7. missionmsa.org missionmsa.org/findingclinicaltrials/

Finding Clinical Trials This initial study of YA-101 in MSA patients will generate data to evaluate the safety, tolerability, pharmacokinetics (PK), and potential efficacy of YA-101 ...

8. ctv.veeva.com ctv.veeva.com/study/a-phase-2-study-of-ya-101-in-patients-with-multiple-system-atrophy

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

9. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386594

ANZCTR - Registration To evaluate the safety and tolerability of YA-101 following multiple ascending oral administration in healthy volunteers. These will be assesed by ...