NCT04075318

Study of UB-312 in Healthy Participants and Parkinson's Disease Patients

A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: United Neuroscience Ltd. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a 44-week, randomized, placebo-controlled, double-blind, single-center, phase 1 clinical trial consisting of a dose-escalation Part A study in healthy participants, followed by a Part B in participants with Parkinson's disease with a selected doses from Part A.

Detailed description

This is a first-in-human Phase 1 study to determine the safety, tolerability, and immunogenicity of UB-312 in healthy participants 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. The study consists of two parts. Part A of the study with healthy participants will consist of dose escalation and cohort staggering for up to seven planned dose levels or placebo. Part B of the study will consist of two cohorts of participants with Parkinson's disease (PD). Dosing for Part B will be based on safety, tolerability and immunogenicity from Part A. All eligible participants will be enrolled in a 44-week study consisting of 20 weeks of treatment and 24 weeks of follow-up.

Conditions

• Parkinson's Disease
• Parkinsonism

Interventions

Type	Name	Description
BIOLOGICAL	UB-312	A synthetic peptide-based vaccine
BIOLOGICAL	Placebo	Matching placebo

Timeline

• Start date: 2019-08-29
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2019-08-30
• Last updated: 2025-03-06
• Results posted: 2025-03-06

Locations

1 site across 1 country: Netherlands