Status:
COMPLETED
Study of UB-312 in Healthy Participants and Parkinson's Disease Patients
Lead Sponsor:
United Neuroscience Ltd.
Collaborating Sponsors:
Centre for Human Drug Research, Netherlands
Worldwide Clinical Trials
Conditions:
Parkinson's Disease
Parkinsonism
Eligibility:
All Genders
40-85 years
Phase:
PHASE1
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 par...
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®...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04075318
Start Date
August 29 2019
End Date
March 1 2023
Last Update
March 6 2025
Active Locations (1)
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1
Centre for Human Drug Research
Leiden, Netherlands