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

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.

Inclusion Criteria:

• Male or female aged 40 to 85 years old, inclusive at screening
• Expected to be able to undergo all study procedures
• Other inclusion criteria apply

For Part B only:

• A diagnosis of PD, confirmed by a neurologist
• Hoehn &Yahr Stage ≤ III at Screening
• Stable treatment of permitted antiparkinsonian medications from 30 days prior to first study drug administration or 60 days for MAO-B inhibitors, and expected to remain stable throughout the study

Exclusion Criteria:

• Clinically significant abnormalities, as judged by the investigator
• History of medical, neurological or psychiatric conditions which in the opinion of the investigator may compromise participant's safety or scientific value of the study
• Acute or chronic infection as judged by the investigator, for positive human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)
• History or evidence of an autoimmune disorder
• History of anergy.
• Participated/participating in any clinical trial with monoclonal antibodies or vaccines directed at aSyn
• Other exclusion criteria apply

For Part B only:

• Other known or suspected cause of Parkinsonism other than idiopathic PD
• History or evidence at Screening of PD-related freezing episodes, falls, or orthostatic hypotension
• Dopamine transporter single-photon emission computerized tomography scan (DaTscan) inconsistent with dopamine transporter deficit.
• Clinically significant neurological disease other than PD