Parkinson's Disease (PD)
Conditions
Keywords
PD, TB006, Monoclonal Antibody, Parkinson's Disease
Brief summary
The primary objectives of this study are to assess the efficacy of TB006 in improving motor function and to assess the safety of TB006 in participants with Parkinson's Disease (PD).
Interventions
DRUGTB006
IV infusion.
DRUGPlacebo
IV infusion.
Sponsors
TrueBinding, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Participants voluntarily agree to participate in this study and sign an Institutional Review Board (IRB)-approved informed consent form (ICF) prior to performing any of the screening procedures. Parkinson's Disease Related Criteria: 2. Diagnosis of Parkinson's disease (PD) with motor symptom improvement from levodopa, if applicable. 3. Less than 5 years from the initial PD diagnosis, at the time of ICF. 4. Early-stage PD, with mild symptoms based on standard clinical staging in OFF state. 5. Participants who are on immediate-release levodopa-carbidopa/benserazide. Other Health Related Criteria 6. No active cancer, unless in remission for ≥10 years without ongoing treatment, except fully removed basal cell carcinoma. 7. Free of significant health issues that might interfere with study participation. Other Criteria/Social Circumstances 8. Negative screening for illegal drugs (excluding cannabis), with willingness to abstain during the study and avoid cannabis or alcohol effects during visits.
Exclusion criteria
Parkinsons's Disease Related Criteria 1. History of sudden, unexpected PD medication OFF episodes. 2. Severe motor complications or disabling symptoms that may impact study involvement. Other Health Related Criteria 3. Any condition or health concern deemed a safety risk or likely to interfere with study results. 4. Severe psychiatric disorders, including psychosis or substance addiction. 5. Allergies or sensitivities to specific study-related treatments or substances. 6. Any prior history of a severe infusion reaction. Other Criteria/Social Circumstances 7. Pregnancy, breastfeeding, or plans for pregnancy or ova donation during or shortly after the study. 8. Recent use of investigational drugs or therapeutic antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Parkinson's Disease Rating Scale Score | Baseline to 28 weeks |
| Number of Participants Experiencing Adverse Events | 28 weeks |
| Number of Participants Experiencing Serious Adverse Events | 28 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Parkinson's Disease Rating Scale Sub-score | Baseline to 28 weeks |
| Change from Baseline in Patient Perceived Severity of Disease | Baseline to 28 weeks |
| Change from Baseline in Clinician Perceived Severity of Disease | Baseline to 28 weeks |
Countries
United States
Outcome results
None listed