Parkinson's disease
Conditions
Interventions
UBITh® PD Immunotherapeutic Vaccine (UB-312)
Sponsors
United Neuroscience (Subsidiary of Vaxxinity)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants may be included in the clinical trial only if they meet all of the following criteria: 1. Written informed consent is signed and dated by the participant 2. Male or female aged 40 to 85 years old, inclusive at screening 3. Participants must have a body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening, and with a minimum weight of 50 kg 4. Expected to be able to undergo all study procedures 5. Women must be of non-childbearing potential (postmenopausal for at least 12 months prior to screening or surgically sterile documented) or if of child-bearing potential, must be using medically acceptable contraceptive measures throughout the duration of the study and for at least 56 weeks after their last dose of study treatment. 6. Male participants and their partners of childbearing potential must commit to the use of medically acceptable contraception for the study duration and for at least 90 days after their last dose of study treatment. Men must refrain from donating sperm during this same period. The female partners should be asked to use a contraception method that is medically acceptable, and these contraceptive measures should be used throughout the duration of the study and for at least 90 days after their last dose of study treatment. For Part B only: 7. A diagnosis of PD, confirmed by a neurologist 8. Hoehn & Yahr Stage
Exclusion criteria
Exclusion criteria: Participants will be excluded from the clinical trial for any of the following reasons: 1. Clinically significant abnormalities, as judged by the investigator, in test results (including hepatic and renal panels, complete blood count, chemistry panel, urinalysis and imaging). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant. 2. 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, posing an unacceptable risk to the participant or interfere with the participant's ability to comply with study procedures or abide by study restrictions. 3. History of Substance Use Disorder within the past 2 years before screening (Diagnostic and Statistical Manual of Mental Disorders-5 [DSM-V] criteria) or confirmed drugs of abuse or alcohol at Screening. Positive urine drug screen for prescribed medication is allowed at the discretion of the PI. 4. Acute or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) at Screening, or any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV-1, HIV-2 infection, cytotoxic therapy in the previous 5 years. 5. History or evidence of an autoimmune disorder (e.g. Sjogren*s syndrome, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis etc.), which in the opinion of the investigator may compromise patient*s safety or scientific value of the study, posing an unacceptable risk to the participant. 6. Level of anti-cyclic citrullinated peptide (anti-CCP) above upper limit of normal at Screening. 7. Positive antinuclear antibodies (ANA) except judged to be clinically irrelevant by the investigator. 8. History of anergy. 9. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or vaccine, or multiple drug allergies (non-active hay fever is acceptable). 10. History of cancer (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved) which has not been in remission for at least 5 years prior to Screening. 11. Clinically significant abnormal ECG or blood pressure measurement at screening or before the first dosing, as judged by the Investigator. 12. Contraindication to MRI, including but not limited to the presence of metal devices or implants (e.g. pacemaker, vascular- or heart-valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes. 13. Receipt of an investigational product or device, or participation in a drug research study within a period of 90 days before baseline at V1. 14. Participated/participating in any clinical trial with monoclonal antibodies or vaccines directed against aSyn. 15. Underwent any procedures/studies involving intracranial surgery, implantation of a device into the brain or stem cell study. 16. Pregnancy confirmed by a positive pregnancy test. 17. Participants who are currently breastfeeding, intend to breastfeed during the study or are planning to get pregnant and breastfeed within 56 weeks after last injection. 18. Use of any prohibited medi
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| N.A. Only primary and exploratory end points. | — |
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures Safety and tolerability will be assessed by adverse events (AEs), clinical laboratory assessments, vital signs, neurological and physical examinations, electrocardiograms (ECG), and safety MRI if applicable. Immunogenicity will be measured by change from baseline of blood and CSF anti-aSyn antibody titers. | — |
Countries
Netherlands
Outcome results
None listed