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A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease

NCT06773962 · TrueBinding, Inc.
In plain English

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Official title
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of TB006 in Participants With Parkinson's Disease
About this study
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).
Eligibility criteria
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.
Study design
Enrollment target: 62 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-03-20
Estimated completion: 2026-09-01
Last updated: 2025-12-12
Interventions
Drug: TB006Drug: Placebo
Primary outcomes
  • 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)
Sponsor
TrueBinding, Inc. · industry
Contacts & investigators
ContactTrueBinding, Inc. · contact · clinicaltrial@truebinding.com · 650-847-1117
All locations (14)
Parkinson's Research Centers of America - Orange CountyRecruiting
Aliso Viejo, California, United States
Parkinson's Research Centers of America - Palo AltoRecruiting
Palo Alto, California, United States
CenExel Rocky Mountain Clinical ResearchRecruiting
Englewood, Colorado, United States
Parkinson's Disease and Movement Disorders Center of Boca RatonRecruiting
Boca Raton, Florida, United States
University of MiamiRecruiting
Miami, Florida, United States
University of South Florida Parkinson's and Movement Disorders CenterRecruiting
Tampa, Florida, United States
Consultants in Neurology, LtdRecruiting
Northbrook, Illinois, United States
Josephson Wallack Munshower Neurology - SoutheastRecruiting
Indianapolis, Indiana, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Quest Research InstituteRecruiting
Farmington Hills, Michigan, United States
Parkinson's Research Centers of America - Long IslandRecruiting
Commack, New York, United States
NYU Langone HealthRecruiting
Patchogue, New York, United States
Oregon Health & Science UniversityRecruiting
Portland, Oregon, United States
Central Texas Neurology ConsultantsRecruiting
Round Rock, Texas, United States