NCT05634876

UB-312 in Patients With Synucleinopathies

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Multiple System Atrophy
• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-31
• Primary completion: 2025-02-11
• Completion: 2025-02-11
• First posted: 2022-12-02
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study