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UB-312 in Patients With Synucleinopathies

NCT05634876 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

UB-312 Injection

UB-312, provided by Vaxxinity, contains 300 μg of p4573kb Drug Substance (synthetic peptide immunogen) formulated with CpG1 and Adju-Phos as a white, opaque, liquid suspension. The biological will be injected intramuscularly. The injection site will be the deltoid muscle.

BIOLOGICAL

Placebo Injection

Placebo will be injected intramuscularly. The injection site will be the deltoid muscle.

Sponsors & Collaborators

Principal Investigators

  • Horacio Kaufmann, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2025-02-11
Completion
2025-02-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05634876 on ClinicalTrials.gov