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

Last updated: April 2, 2025
Sponsor: TrueBinding, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

TB006

Clinical Study ID

NCT06773962
TB006PD2101
  • Ages 50-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants voluntarily agree to participate in this study and sign anInstitutional Review Board (IRB)-approved informed consent form (ICF) prior toperforming 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 toabstain during the study and avoid cannabis or alcohol effects during visits.

Exclusion

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 withstudy 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 shortlyafter the study.

  8. Recent use of investigational drugs or therapeutic antibodies.

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 20, 2025
Estimated Completion Date:
December 29, 2025

Connect with a study center

  • Parkinson's Research Centers of America - Orange County

    Aliso Viejo, California 92656
    United States

    Active - Recruiting

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Josephson Wallack Munshower Neurology - Southeast

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

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