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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-29

Study Completion Date

2023-03-01

Brief Summary

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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.

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Detailed Description

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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

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Parkinson's Disease Parkinsonism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: UB-312 40 mcg

UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13

Group Type EXPERIMENTAL

UB-312

Intervention Type BIOLOGICAL

A synthetic peptide-based vaccine

Part A: UB-312 100 mcg

UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13

Group Type EXPERIMENTAL

UB-312

Intervention Type BIOLOGICAL

A synthetic peptide-based vaccine

Part A: UB-312 40/300 mcg

UB-312 40 mcg at Week 1 and 300 mcg at Weeks 5 and 13 by intramuscular injection

Group Type EXPERIMENTAL

UB-312

Intervention Type BIOLOGICAL

A synthetic peptide-based vaccine

Part A: UB-312 300 mcg

UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13

Group Type EXPERIMENTAL

UB-312

Intervention Type BIOLOGICAL

A synthetic peptide-based vaccine

Part A: UB-312 40/1000 mcg

UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection

Group Type EXPERIMENTAL

UB-312

Intervention Type BIOLOGICAL

A synthetic peptide-based vaccine

Part A: UB-312 1000 mcg

UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13

Group Type EXPERIMENTAL

UB-312

Intervention Type BIOLOGICAL

A synthetic peptide-based vaccine

Part A: UB-312 2000 mcg

UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13

Group Type EXPERIMENTAL

UB-312

Intervention Type BIOLOGICAL

A synthetic peptide-based vaccine

Part A: Placebo

Placebo by intramuscular injection at Weeks 1, 5 and 13

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Matching placebo

Part B: UB-312 300/100 mcg

UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection

Group Type EXPERIMENTAL

UB-312

Intervention Type BIOLOGICAL

A synthetic peptide-based vaccine

Part B: UB-312 300 mcg

UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection

Group Type EXPERIMENTAL

UB-312

Intervention Type BIOLOGICAL

A synthetic peptide-based vaccine

Part B: Placebo

Placebo by intramuscular injection at Weeks 1, 5 and 13

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Matching placebo

Interventions

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UB-312

A synthetic peptide-based vaccine

Intervention Type BIOLOGICAL

Placebo

Matching placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 40 to 85 years old, inclusive at screening
* Expected to be able to undergo all study procedures

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

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes