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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075318
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Centre for Human Drug Research, Netherlands
Worldwide Clinical Trials
Information provided by (Responsible Party):
United Neuroscience Ltd.

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 dose from Part A.

Condition or disease Intervention/treatment Phase
Parkinson Disease Parkinsonism Biological: UB-312 Biological: Placebo Phase 1

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. The dose for Part B, a cohort with PD participants will be based on safety, tolerability and immunogenicity. All eligible participants will be enrolled in a 44-week study consisting of 20 weeks of treatment and 24 weeks of follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 29, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UB-312 40 ug
UB-312 40 ug by intramuscular injection at Weeks 1, 5 and 13
Biological: UB-312
A synthetic peptide-based vaccine

Experimental: UB-312 100 ug
UB-312 100 ug by intramuscular injection at Weeks 1, 5 and 13
Biological: UB-312
A synthetic peptide-based vaccine

Experimental: UB-312 40/300 ug
UB-312 40 ug at Week 1 and 300 ug at Weeks 5 and 13 by intramuscular injection
Biological: UB-312
A synthetic peptide-based vaccine

Experimental: UB-312 300 ug
UB-312 300 ug by intramuscular injection at Weeks 1, 5 and 13
Biological: UB-312
A synthetic peptide-based vaccine

Experimental: UB-312 40/1000 ug
UB-312 40 ug at Week 1 and 1000 ug at Weeks 5 and 13 by intramuscular injection
Biological: UB-312
A synthetic peptide-based vaccine

Experimental: UB-312 1000 ug
UB-312 1000 ug by intramuscular injection at Weeks 1, 5 and 13
Biological: UB-312
A synthetic peptide-based vaccine

Experimental: UB-312 2000 ug
UB-312 2000 ug by intramuscular injection at Weeks 1, 5 and 13
Biological: UB-312
A synthetic peptide-based vaccine

Placebo Comparator: Placebo
Placebo by intramuscular injection at Weeks 1, 5 and 13
Biological: Placebo
Matching placebo




Primary Outcome Measures :
  1. Frequency of Adverse Events [ Time Frame: 44 weeks ]
    Number of AEs will be assessed

  2. Immunogenicity of UB-312 as determined by anti-aSyn antibodies in blood and CSF [ Time Frame: Weeks 1, 2, 5, 6, 9, 13, 14, 17 and 21 ]
    Immunogenicity will be measured by change from baseline of blood and CSF anti-aSyn antibody titers.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Active 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075318


Contacts
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Contact: Clinical Trial Manager +353 1 524 0397 ub312101@unitedneuroscience.com

Locations
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Netherlands
Centre for Human Drug Research Recruiting
Leiden, Netherlands
Principal Investigator: Geert Jan Groeneveld, MD, MSc, PhD         
Sponsors and Collaborators
United Neuroscience Ltd.
Centre for Human Drug Research, Netherlands
Worldwide Clinical Trials
Publications:
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Responsible Party: United Neuroscience Ltd.
ClinicalTrials.gov Identifier: NCT04075318    
Other Study ID Numbers: UB-312-101
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases