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

Primary Purpose

Parkinson's Disease, Parkinsonism

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

UB-312

Placebo

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Centre for Human Drug Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

UB-312 40 mcg

UB-312 100 mcg

UB-312 40/300 mcg

UB-312 300 mcg

UB-312 40/1000 mcg

UB-312 1000 mcg

UB-312 2000 mcg

Placebo

UB-312 300/100 mcg

Arm Description

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

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

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

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

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

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

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

Placebo by intramuscular injection at Weeks 1, 5 and 13

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

Outcomes

Primary Outcome Measures

Frequency of Adverse Events

Number of AEs will be assessed

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04075318

First Posted

August 5, 2019

Last Updated

March 20, 2023

Sponsor

United Neuroscience Ltd.

Collaborators

Centre for Human Drug Research, Netherlands, Worldwide Clinical Trials, Vaxxinity, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04075318

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 29, 2019 (Actual)

Primary Completion Date

March 1, 2023 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

United Neuroscience Ltd.

Collaborators

Centre for Human Drug Research, Netherlands, Worldwide Clinical Trials, Vaxxinity, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease, Parkinsonism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UB-312 40 mcg

Arm Type

Experimental

Arm Description

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

Arm Title

UB-312 100 mcg

Arm Type

Experimental

Arm Description

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

Arm Title

UB-312 40/300 mcg

Arm Type

Experimental

Arm Description

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

Arm Title

UB-312 300 mcg

Arm Type

Experimental

Arm Description

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

Arm Title

UB-312 40/1000 mcg

Arm Type

Experimental

Arm Description

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

Arm Title

UB-312 1000 mcg

Arm Type

Experimental

Arm Description

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

Arm Title

UB-312 2000 mcg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo by intramuscular injection at Weeks 1, 5 and 13

Arm Title

UB-312 300/100 mcg

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

UB-312

Intervention Description

A synthetic peptide-based vaccine

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Matching placebo

Primary Outcome Measure Information:

Title

Frequency of Adverse Events

Description

Number of AEs will be assessed

Time Frame

44 weeks

Title

Immunogenicity of UB-312 as determined by anti-aSyn antibodies in blood and CSF

Description

Immunogenicity will be measured by change from baseline of blood anti-aSyn antibody titers.

Time Frame

Weeks 1, 2, 5, 6, 9, 13, 14, 17, 21, 29, 37 and 45

Title

Immunogenicity of UB-312 as determined by anti-aSyn antibodies in blood and CSF

Description

Immunogenicity will be measured by change from baseline of CSF anti-aSyn antibody titers

Time Frame

Weeks 1, 21 and 45

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dario Mirski, MD

Organizational Affiliation

Vaxxinity, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Centre for Human Drug Research

City

Leiden

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15755569

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.

Results Reference

background

PubMed Identifier

17287052

Citation

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.

Results Reference

background

PubMed Identifier

29067332

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.

Results Reference

background

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

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