Parkinson's DiseasePhase 1NCT04075318
Study of UB-312 in Healthy Participants and Parkinson's Disease Patients
A Phase 1 study testing UB-312 in people with Parkinson's Disease and Parkinsonism, run by United Neuroscience Ltd. at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Parkinsonism
- What is being tested?
- UB-312
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Aug 2019to 1 Mar 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Parkinson's Disease, Parkinsonism
- Being tested
- UB-312, Placebo
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-312Biological
A synthetic peptide-based vaccine
PlaceboBiological
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A: UB-312 40 mcg | Experimental | UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13 Receives: Biological: UB-312 |
| Part A: UB-312 100 mcg | Experimental | UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13 Receives: Biological: UB-312 |
| Part A: UB-312 40/300 mcg | Experimental | UB-312 40 mcg at Week 1 and 300 mcg at Weeks 5 and 13 by intramuscular injection Receives: Biological: UB-312 |
| Part A: UB-312 300 mcg | Experimental | UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13 Receives: Biological: UB-312 |
| Part A: UB-312 40/1000 mcg | Experimental | UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection Receives: Biological: UB-312 |
| Part A: UB-312 1000 mcg | Experimental | UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13 Receives: Biological: UB-312 |
| Part A: UB-312 2000 mcg | Experimental | UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13 Receives: Biological: UB-312 |
| Part A: Placebo | Placebo comparator | Placebo by intramuscular injection at Weeks 1, 5 and 13 Receives: Biological: Placebo |
| Part B: UB-312 300/100 mcg | Experimental | UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection Receives: Biological: UB-312 |
| Part B: UB-312 300 mcg | Experimental | UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection Receives: Biological: UB-312 |
| Part B: Placebo | Placebo comparator | Placebo by intramuscular injection at Weeks 1, 5 and 13 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Number of AEs will be assessed
Measured: 44 weeks
Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in Blood
Number of Participants with Anti-aSyn Antibodies in Blood from Weeks 1 through 45.
Measured: 44 weeks
Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in CSF
Number of Participants with Anti-aSyn Antibodies in CSF from Weeks 1 through 45.
Measured: 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start29 Aug 2019
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Neuroscience Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Human Drug Research, Netherlands, Worldwide Clinical Trials, Vaxxinity, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Vaxxinity, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075318
- Sponsor's protocol ID
- UB-312-101
- Status last verified
- Feb 2025
- First submitted
- 5 Aug 2019
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15755569Wang 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.
PubMed 17287052Wang 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.
PubMed 29067332Eijsvogel P, Misra P, Concha-Marambio L, Boyd JD, Ding S, Fedor L, Hsieh YT, Sun YS, Vroom MM, Farris CM, Ma Y, de Kam ML, Radanovic I, Vissers MFJM, Mirski D, Shareghi G, Shahnawaz M, Singer W, Kremer P, Groeneveld GJ, Yu HJ, Dodart JC. Target engagement and immunogenicity of an active immunotherapeutic targeting pathological alpha-synuclein: a phase 1 placebo-controlled trial. Nat Med. 2024 Sep;30(9):2631-2640. doi: 10.1038/s41591-024-03101-8. Epub 2024 Jun 20.
PubMed 38902546Yu HJ, Thijssen E, van Brummelen E, van der Plas JL, Radanovic I, Moerland M, Hsieh E, Groeneveld GJ, Dodart JC. A Randomized First-in-Human Study With UB-312, a UBITh(R) alpha-Synuclein Peptide Vaccine. Mov Disord. 2022 Jul;37(7):1416-1424. doi: 10.1002/mds.29016. Epub 2022 Apr 15.
PubMed 35426173
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04075318
- Acronym / sponsor ID
- UB-312-101
- Conditions
- Parkinson's Disease, Parkinsonism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- United Neuroscience Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Centre for Human Drug Research, Netherlands, Worldwide Clinical Trials, Vaxxinity, Inc.
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Posted 6 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A: UB-312 40 mcg | Experimental | Biological: UB-312UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13 |
| Part A: UB-312 100 mcg | Experimental | Biological: UB-312UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13 |
| Part A: UB-312 40/300 mcg | Experimental | Biological: UB-312UB-312 40 mcg at Week 1 and 300 mcg at Weeks 5 and 13 by intramuscular injection |
| Part A: UB-312 300 mcg | Experimental | Biological: UB-312UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13 |
| Part A: UB-312 40/1000 mcg | Experimental | Biological: UB-312UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection |
| Part A: UB-312 1000 mcg | Experimental | Biological: UB-312UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13 |
| Part A: UB-312 2000 mcg | Experimental | Biological: UB-312UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13 |
| Part A: Placebo | Placebo comparator | Biological: PlaceboPlacebo by intramuscular injection at Weeks 1, 5 and 13 |
| Part B: UB-312 300/100 mcg | Experimental | Biological: UB-312UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection |
| Part B: UB-312 300 mcg | Experimental | Biological: UB-312UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection |
| Part B: Placebo | Placebo comparator | Biological: PlaceboPlacebo by intramuscular injection at Weeks 1, 5 and 13 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- A diagnosis of PD, confirmed by a neurologist
- Hoehn \&Yahr Stage ≤ III at Screening
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UB-312A synthetic peptide-based vaccine | Biological | Part A: UB-312 100 mcg, Part A: UB-312 1000 mcg, Part A: UB-312 2000 mcg, Part A: UB-312 300 mcg, Part A: UB-312 40 mcg, Part A: UB-312 40/1000 mcg, Part A: UB-312 40/300 mcg, Part B: UB-312 300 mcg, Part B: UB-312 300/100 mcg |
| PlaceboMatching placebo | Biological | Part A: Placebo, Part B: Placebo |
Primary outcome
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
Time frame: 44 weeks
Number of Participants with Anti-aSyn Antibodies in Blood from Weeks 1 through 45.
Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in CSF
Time frame: 44 weeks
Number of Participants with Anti-aSyn Antibodies in CSF from Weeks 1 through 45.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15755569Wang 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.
- Background: PubMed 17287052Wang 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.
- Background: PubMed 29067332Wang 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 publication: PubMed 38902546Eijsvogel P, Misra P, Concha-Marambio L, Boyd JD, Ding S, Fedor L, Hsieh YT, Sun YS, Vroom MM, Farris CM, Ma Y, de Kam ML, Radanovic I, Vissers MFJM, Mirski D, Shareghi G, Shahnawaz M, Singer W, Kremer P, Groeneveld GJ, Yu HJ, Dodart JC. Target engagement and immunogenicity of an active immunotherapeutic targeting pathological alpha-synuclein: a phase 1 placebo-controlled trial. Nat Med. 2024 Sep;30(9):2631-2640. doi: 10.1038/s41591-024-03101-8. Epub 2024 Jun 20.
- Results publication: PubMed 35426173Yu HJ, Thijssen E, van Brummelen E, van der Plas JL, Radanovic I, Moerland M, Hsieh E, Groeneveld GJ, Dodart JC. A Randomized First-in-Human Study With UB-312, a UBITh(R) alpha-Synuclein Peptide Vaccine. Mov Disord. 2022 Jul;37(7):1416-1424. doi: 10.1002/mds.29016. Epub 2022 Apr 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director, MD study director
Vaxxinity, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UB-312 in people with Parkinson's Disease and Parkinsonism, run by United Neuroscience Ltd. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (time frame: 44 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04075318, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.