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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04075318 |
Recruitment Status :
Completed
First Posted : August 30, 2019
Last Update Posted : December 5, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease Parkinsonism | Biological: UB-312 Biological: Placebo | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 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 |
Actual Primary Completion Date : | March 1, 2023 |
Actual Study Completion Date : | March 1, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: UB-312 40 mcg
UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13
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Biological: UB-312
A synthetic peptide-based vaccine |
Experimental: UB-312 100 mcg
UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13
|
Biological: UB-312
A synthetic peptide-based vaccine |
Experimental: UB-312 40/300 mcg
UB-312 40 mcg at Week 1 and 300 mcg at Weeks 5 and 13 by intramuscular injection
|
Biological: UB-312
A synthetic peptide-based vaccine |
Experimental: UB-312 300 mcg
UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13
|
Biological: UB-312
A synthetic peptide-based vaccine |
Experimental: UB-312 40/1000 mcg
UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection
|
Biological: UB-312
A synthetic peptide-based vaccine |
Experimental: UB-312 1000 mcg
UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13
|
Biological: UB-312
A synthetic peptide-based vaccine |
Experimental: UB-312 2000 mcg
UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13
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Biological: UB-312
A synthetic peptide-based vaccine |
Placebo Comparator: Placebo
Placebo by intramuscular injection at Weeks 1, 5 and 13
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Biological: Placebo
Matching placebo |
Experimental: UB-312 300/100 mcg
UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection
|
Biological: UB-312
A synthetic peptide-based vaccine |
- Frequency of Adverse Events [ Time Frame: 44 weeks ]Number of AEs will be assessed
- 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, 21, 29, 37 and 45 ]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 [ Time Frame: Weeks 1, 21 and 45 ]Immunogenicity will be measured by change from baseline of CSF anti-aSyn antibody titers
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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
Netherlands | |
Centre for Human Drug Research | |
Leiden, Netherlands |
Study Director: | Dario Mirski, MD | Vaxxinity, Inc. |
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: | December 5, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |