A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease
NCT ID: NCT06773962
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
62 participants
INTERVENTIONAL
2025-03-20
2025-12-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TB006
Participants will receive TB006 via intravenous (IV) infusion.
TB006
IV infusion.
Placebo
Participants will receive placebo via IV infusion.
Placebo
IV infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TB006
IV infusion.
Placebo
IV infusion.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
50 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TrueBinding, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Parkinson's Research Centers of America - Orange County
Aliso Viejo, California, United States
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida Parkinson's and Movement Disorders Center
Tampa, Florida, United States
Consultants in Neurology, Ltd
Northbrook, Illinois, United States
Josephson Wallack Munshower Neurology - Southeast
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Parkinson's Research Centers of America - Long Island
Commack, New York, United States
NYU Langone Health
Patchogue, New York, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TB006PD2101
Identifier Type: -
Identifier Source: org_study_id