Phase 1 Completed N=70 Randomized Quadruple-blind Treatment

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

Parkinson's Disease · Parkinsonism

Source: ClinicalTrials.gov NCT04075318 ↗

Enrolled (actual)

Serious AEs

4.3%

Results posted

Mar 2025

Primary outcomePrimary: Frequency of Adverse Events — 22; 31; 25; 31 TEAEs

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Frequency of Adverse Events	22; 31; 25; 31; 24; 17	—
PRIMARY Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in Blood	5; 5; 5; 6; 0; 0	—
PRIMARY Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in CSF	1; 4; 3; 6; 0; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04075318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.