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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075318
• Other study ID #: UB-312-101
• Status: Completed
• Phase: Phase 1
• Start date: August 29, 2019
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2023
• Source: United Neuroscience Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Parkinsonian Disorders
• Parkinsonism

Intervention

Biological:
• UB-312
A synthetic peptide-based vaccine
• Placebo
Matching placebo

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Leiden

Sponsors (4)

Lead Sponsor	Collaborator
United Neuroscience Ltd.	Centre for Human Drug Research, Netherlands, Vaxxinity, Inc., Worldwide Clinical Trials

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Wang CY, Finstad CL, Walfield AM, Sia C, Sokoll KK, Chang TY, Fang XD, Hung CH, Hutter-Paier B, Windisch M. Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. Vaccine. 2007 Apr 20;25(16):3041-52. doi: 10.1016/j.vaccine.2007.01.031. Epub 2007 Jan 19. — View Citation

Wang CY, Walfield AM. Site-specific peptide vaccines for immunotherapy and immunization against chronic diseases, cancer, infectious diseases, and for veterinary applications. Vaccine. 2005 Mar 18;23(17-18):2049-56. doi: 10.1016/j.vaccine.2005.01.007. — View Citation

Wang CY, Wang PN, Chiu MJ, Finstad CL, Lin F, Lynn S, Tai YH, De Fang X, Zhao K, Hung CH, Tseng Y, Peng WJ, Wang J, Yu CC, Kuo BS, Frohna PA. UB-311, a novel UBITh(R) amyloid beta peptide vaccine for mild Alzheimer's disease. Alzheimers Dement (N Y). 2017 Apr 14;3(2):262-272. doi: 10.1016/j.trci.2017.03.005. eCollection 2017 Jun. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Adverse Events	Number of AEs will be assessed	44 weeks
Primary	Immunogenicity of UB-312 as determined by anti-aSyn antibodies in blood and CSF	Immunogenicity will be measured by change from baseline of blood anti-aSyn antibody titers.	Weeks 1, 2, 5, 6, 9, 13, 14, 17, 21, 29, 37 and 45
Primary	Immunogenicity of UB-312 as determined by anti-aSyn antibodies in blood and CSF	Immunogenicity will be measured by change from baseline of CSF anti-aSyn antibody titers	Weeks 1, 21 and 45