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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Centre for Human Drug Research
Leiden, Netherlands
Frequency of Adverse Events
Number of AEs will be assessed
Time frame: 44 weeks
Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in Blood
Number of Participants with Anti-aSyn Antibodies in Blood from Weeks 1 through 45.
Time frame: 44 weeks
Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in CSF
Number of Participants with Anti-aSyn Antibodies in CSF from Weeks 1 through 45.
Time frame: 44 weeks
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