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

Phase 2

Recruiting

• Conditions: Parkinson's Disease (PD)
• Interventions: Drug: TB006; Drug: Placebo

• Registration Number: NCT06773962
• Lead Sponsor: TrueBinding, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-14
• Study Start: 2025-03-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-12-29
• Study Completion: 2025-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TB006	TB006	Participants will receive TB006 via intravenous (IV) infusion.
Placebo	Placebo	Participants will receive placebo via IV infusion.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Parkinson's Disease Rating Scale Sub-score	Baseline to 28 weeks
Change from Baseline in Patient Perceived Severity of Disease	Baseline to 28 weeks
Change from Baseline in Clinician Perceived Severity of Disease	Baseline to 28 weeks

Trial Locations

Locations (6)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Central Texas Neurology Consultants; 🇺🇸 Round Rock, Texas, United States

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

Parkinson's Disease and Movement Disorders Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

Josephson Wallack Munshower Neurology - Southeast; 🇺🇸 Indianapolis, Indiana, United States

Quest Research Institute; 🇺🇸 Farmington Hills, Michigan, United States