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

April 21, 2026 updated by: TrueBinding, Inc.

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of TB006 in Participants With Parkinson's Disease

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Aliso Viejo, California, United States, 92656
        • Parkinson's Research Centers of America - Orange County
      • Palo Alto, California, United States, 94301
        • Parkinson's Research Centers of America - Palo Alto
    • Colorado
      • Englewood, Colorado, United States, 80113
        • CenExel Rocky Mountain Clinical Research
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
      • Miami, Florida, United States, 33136
        • University of Miami
      • Tampa, Florida, United States, 33613
        • University of South Florida Parkinson's and Movement Disorders Center
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Consultants in Neurology, Ltd
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Josephson Wallack Munshower Neurology - Southeast
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute
    • New York
      • Commack, New York, United States, 11725
        • Parkinson's Research Centers of America - Long Island
      • Patchogue, New York, United States, 11772
        • NYU Langone Health
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Texas
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TB006
Participants will receive TB006 via intravenous (IV) infusion.
Drug: TB006
IV infusion.
Placebo Comparator: Placebo
Participants will receive placebo via IV infusion.
Drug: Placebo
IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Parkinson's Disease Rating Scale Score
Time Frame: Baseline to 28 weeks
Baseline to 28 weeks
Number of Participants Experiencing Adverse Events
Time Frame: 28 weeks
28 weeks
Number of Participants Experiencing Serious Adverse Events
Time Frame: 28 weeks
28 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Parkinson's Disease Rating Scale Sub-score
Time Frame: Baseline to 28 weeks
Baseline to 28 weeks
Change from Baseline in Patient Perceived Severity of Disease
Time Frame: Baseline to 28 weeks
Baseline to 28 weeks
Change from Baseline in Clinician Perceived Severity of Disease
Time Frame: Baseline to 28 weeks
Baseline to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TrueBinding, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2025

Primary Completion (Estimated)

November 28, 2026

Study Completion (Estimated)

November 28, 2026

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

January 14, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB006PD2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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