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

TrueBinding

Status and phase: Enrolling; Phase 2

Conditions: Parkinson's Disease (PD)

Treatments: Drug: TB006; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06773962

TB006PD2101

Details and patient eligibility

About

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).

Enrollment: 62 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups, including a placebo group

TB006

Experimental group

Description:

Participants will receive TB006 via intravenous (IV) infusion.

Treatment:

Drug: TB006

Placebo

Placebo Comparator group

Description:

Participants will receive placebo via IV infusion.

Treatment:

Drug: Placebo