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NCT05634876 · ClinicalTrials.gov registry record · Phase 1
UB-312 in Patients With Synucleinopathies
A Phase 1 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT05634876: Completed Phase 1 study, sponsored by NYU Langone Health.
NCT05634876 is a Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05634876, a Phase 1 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a Phase 1b study to determine the safety, tolerability, and immunogenicity of UB-312 in participants with multiple system atrophy (MSA), 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; and the most rapidly progressive form, MSA.
Primary Outcome
Derived from participant serum samples and calculated using a validated enzyme immunoassay.
Interventions
- BIOLOGICAL UB-312 Injection
- BIOLOGICAL Placebo Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-05-31 |
| Est. Completion | 2025-02-11 |
| Phase | Phase 1 |
What the finished NCT05634876 record still lists
NCT05634876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which UB-312 Injection is the first listed.
NCT05634876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05634876 about?
NCT05634876 is a clinical study titled "UB-312 in Patients With Synucleinopathies". This is a Phase 1b study to determine the safety, tolerability, and immunogenicity of UB-312 in participants with multiple system atrophy (MSA), and in participants with Parkinson's disease (PD). UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine and may provide an active immunotherapy opti...
What is the current status of trial NCT05634876?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2023-05-31. Estimated completion is 2025-02-11.
What interventions are being tested in trial NCT05634876?
The interventions under investigation include: UB-312 Injection (BIOLOGICAL), Placebo Injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT05634876?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05634876's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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