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

United Neuroscience

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease; Parkinsonism

Treatments: Biological: Placebo; Biological: UB-312

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04075318

UB-312-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

70 participants in 11 patient groups, including a placebo group

Part A: UB-312 40 mcg

Experimental group

Description:

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

Treatment:

Biological: UB-312

Part A: UB-312 100 mcg

Experimental group

Description:

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

Treatment:

Biological: UB-312

Part A: UB-312 40/300 mcg

Experimental group

Description:

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

Treatment:

Biological: UB-312

Part A: UB-312 300 mcg

Experimental group

Description:

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

Treatment:

Biological: UB-312

Part A: UB-312 40/1000 mcg

Experimental group

Description:

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

Treatment:

Biological: UB-312

Part A: UB-312 1000 mcg

Experimental group

Description:

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

Treatment:

Biological: UB-312

Part A: UB-312 2000 mcg

Experimental group

Description:

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

Treatment:

Biological: UB-312

Part A: Placebo

Placebo Comparator group

Description:

Placebo by intramuscular injection at Weeks 1, 5 and 13

Treatment:

Biological: Placebo

Part B: UB-312 300/100 mcg

Experimental group

Description:

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

Treatment:

Biological: UB-312

Part B: UB-312 300 mcg

Experimental group

Description:

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

Treatment:

Biological: UB-312

Part B: Placebo

Placebo Comparator group

Description:

Placebo by intramuscular injection at Weeks 1, 5 and 13

Treatment:

Biological: Placebo