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Active, Not Recruiting

NCT Number: NCT06773962

A Phase 2a Multicenter Clinical Trial 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Parkinson's Research Centers of America - Orange County, Aliso Viejo, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

  • Diagnosis of Parkinson's disease (PD) with motor symptom improvement from levodopa, if applicable.
  • Less than 5 years from the initial PD diagnosis, at the time of ICF.
  • Early-stage PD, with mild symptoms based on standard clinical staging in OFF state.
  • Participants who are on immediate-release levodopa-carbidopa/benserazide.

Other Health Related Criteria

  • No active cancer, unless in remission for ≥10 years without ongoing treatment, except fully removed basal cell carcinoma.
  • Free of significant health issues that might interfere with study participation.

Other Criteria/Social Circumstances

  • 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

  • History of sudden, unexpected PD medication OFF episodes.
  • Severe motor complications or disabling symptoms that may impact study involvement.

Other Health Related Criteria

  • Any condition or health concern deemed a safety risk or likely to interfere with study results.
  • Severe psychiatric disorders, including psychosis or substance addiction.
  • Allergies or sensitivities to specific study-related treatments or substances.
  • Any prior history of a severe infusion reaction.

Other Criteria/Social Circumstances

  • Pregnancy, breastfeeding, or plans for pregnancy or ova donation during or shortly after the study.
  • Recent use of investigational drugs or therapeutic antibodies.

Treatment and study plan

TB006

Drug

IV infusion.

Placebo

Drug

IV infusion.

Primary outcomes

  1. Change from Baseline in Parkinson's Disease Rating Scale Score

    Time frame: Baseline to 28 weeks

  2. Number of Participants Experiencing Adverse Events

    Time frame: 28 weeks

  3. Number of Participants Experiencing Serious Adverse Events

    Time frame: 28 weeks

Secondary outcomes

  1. Change from Baseline in Parkinson's Disease Rating Scale Sub-score

    Time frame: Baseline to 28 weeks

  2. Change from Baseline in Patient Perceived Severity of Disease

    Time frame: Baseline to 28 weeks

  3. Change from Baseline in Clinician Perceived Severity of Disease

    Time frame: Baseline to 28 weeks

Sponsors and collaborators

Lead sponsor

TrueBinding, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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