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UB-312 in Patients With Synucleinopathies | Clinical Trials | Clareo Health

COMPLETEDPHASE1

UB-312 in Patients With Synucleinopathies

A Phase 1b Clinical Trial of UB-312 in Patients With Synucleinopathies

NCT05634876•NYU Langone Health

Summary

This is a Phase 1b study to determine the safety, tolerability, and immunogenicity of UB-312 in participants with multiple system atrophy (MSA), and in participants with Parkinson's disease (PD). UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine and may provide an active immunotherapy option for treating synucleinopathies including the most prevalent form, PD; and the most rapidly progressive form, MSA.

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent is signed and dated by the participant.
•2. Male or female aged 40 to 75 years old, inclusive, at screening.
•3. Participants must have a body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
•4. Expected to be able to undergo all study procedures.
•5. Women must be of non-childbearing potential (postmenopausal for at least 12 months before screening or surgically sterile) or, if of childbearing potential, must be using medically acceptable contraceptive measures throughout the study and for at least 24 weeks after their last dose of study treatment.
•6. Male participants and their partners of childbearing potential must commit to using medically acceptable contraception for the study duration and at least 90 days after their last dose of study treatment. Men must refrain from donating sperm during this same period. The female partners should use a medically acceptable contraception method, and these contraceptive measures should be used throughout the study and for at least 90 days after their last dose of study treatment.
•7. A diagnosis of PD or MSA, confirmed by the PI, as per the current Movement Disorders Society's criteria (Postuma 2015, Wenning 2022).
•8. Stable treatment of permitted antiparkinsonian medications from 30 days before first study drug administration or 60 days for MAO-B inhibitors and expected to remain stable throughout the study unless required adjustment or initiation per the investigator's judgment; except for short-acting rescue medications, which are allowed (see Section 7.1 for the list of permitted medications).
•9. Eligible participants must be fully vaccinated against COVID-19 according to local guidelines. Participants also must have received a COVID-19 booster vaccination, and the interval between booster vaccination and sample collection for inflammatory markers at Screening should be at least seven days.
•10. Subjects with a MOCA score \> 21 at screening and throughout enrollment.

Exclusion Criteria

•1. Clinically significant abnormalities, as judged by the investigator, in test results (including hepatic and renal panels, complete blood count, chemistry panel, a level of anti-cyclic citrullinated peptide (anti-CCP) above the upper limit of normal (ULN) at Screening, positive antinuclear antibodies (ANA), except judged to be clinically irrelevant by the investigator, urinalysis, ECG and imaging), or vital signs. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant.
•2. History of medical, neurological, or psychiatric conditions, which in the opinion of the investigator, may compromise the participant's safety or scientific value of the study, posing an unacceptable risk to the participant or interfering with the participant's ability to comply with the study procedures or abide by study restrictions.
•3. History of Substance Use Disorder within the past 2 years before screening (Diagnostic and Statistical Manual of Mental Disorders-5 \[DSM-V\] criteria).
•4. Acute or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) at Screening or any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV-1, HIV-2 infection, or cytotoxic therapy in the previous 5 years.
•5. History or evidence of an autoimmune disorder (e.g. Sjogren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, etc.), which in the opinion of the investigator may compromise the patient's safety or scientific value of the study, posing an unacceptable risk to the participant.
•6. History of anergy.
•7. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or vaccine, or multiple drug allergies (non-active hay fever is acceptable).
•8. History of cancer (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved) which has not been in remission for at least 5 years before Screening.
•9. Contraindications to MRI, including but not limited to the presence of metal devices or implants (e.g., pacemaker, vascular- or heart-valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes.
•10. Receipt of an investigational product or device, or participation in a drug research study within 90 days before baseline at V1.
+11 more criteria

Locations (1)

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

May 31, 2023

Primary Completion Date

February 11, 2025

Completion Date

February 11, 2025

Last Updated

March 16, 2026

Enrollment

ACTUAL participants

Conditions

Multiple System AtrophyParkinson Disease

Interventions

UB-312 Injection

BIOLOGICAL

Placebo Injection

BIOLOGICAL

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RECRUITINGNA

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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: March 16, 2026Data 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.

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UB-312 in Patients With Synucleinopathies

Inclusion Criteria

Exclusion Criteria

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

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

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