Parkinson's Disease (PD)Phase 2NCT06773962
A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease
A Phase 2 study testing TB006 in people with Parkinson's Disease (PD), run by TrueBinding, Inc. at 14 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- TB006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 14 sitesUnited States
- Study dates
- 20 Mar 2025to 28 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Parkinson's Research Centers of America - Orange County
Aliso Viejo, California, 92656
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Parkinson's Research Centers of America - Long Island
Commack, New York, 11725
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, 80113
Quest Research Institute
Farmington Hills, Michigan, 48334
Josephson Wallack Munshower Neurology - Southeast
Indianapolis, Indiana, 46256
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Miami
Miami, Florida, 33136
Consultants in Neurology, Ltd
Northbrook, Illinois, 60062
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, 94301
NYU Langone Health
Patchogue, New York, 11772
Oregon Health & Science University
Portland, Oregon, 97239
Central Texas Neurology Consultants
Round Rock, Texas, 78681
University of South Florida Parkinson's and Movement Disorders Center
Tampa, Florida, 33613
About this study
Official title: 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).
- Conditions
- Parkinson's Disease (PD)
- Being tested
- TB006, Placebo
- Keywords
- PD, TB006, Monoclonal Antibody, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB006Drug
IV infusion.
PlaceboDrug
IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| TB006 | Experimental | Participants will receive TB006 via intravenous (IV) infusion. Receives: Drug: TB006 |
| Placebo | Placebo comparator | Participants will receive placebo via IV infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Parkinson's Disease Rating Scale Score
Measured: Baseline to 28 weeks
Number of Participants Experiencing Adverse Events
Measured: 28 weeks
Number of Participants Experiencing Serious Adverse Events
Measured: 28 weeks
Secondary outcomes (3)
Change from Baseline in Parkinson's Disease Rating Scale Sub-score
Measured: Baseline to 28 weeks
Change from Baseline in Patient Perceived Severity of Disease
Measured: Baseline to 28 weeks
Change from Baseline in Clinician Perceived Severity of Disease
Measured: Baseline to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start20 Mar 2025
- Primary completion28 Nov 2026 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TrueBinding, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773962
- Sponsor's protocol ID
- TB006PD2101
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of TB006 in Participants With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06773962
- Acronym / sponsor ID
- TB006PD2101
- Conditions
- Parkinson's Disease (PD)
- Keywords
- PD, TB006, Monoclonal Antibody, Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- TrueBinding, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TB006 | Experimental | Drug: TB006Participants will receive TB006 via intravenous (IV) infusion. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo via IV infusion. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB006IV infusion. | Drug | TB006 |
| PlaceboIV infusion. | Drug | Placebo |
Primary outcome
Change from Baseline in Parkinson's Disease Rating Scale Score
Time frame: Baseline to 28 weeks
Number of Participants Experiencing Adverse Events
Time frame: 28 weeks
Number of Participants Experiencing Serious Adverse Events
Time frame: 28 weeks
3 secondary outcomes
Change from Baseline in Parkinson's Disease Rating Scale Sub-score
Time frame: Baseline to 28 weeks
Change from Baseline in Patient Perceived Severity of Disease
Time frame: Baseline to 28 weeks
Change from Baseline in Clinician Perceived Severity of Disease
Time frame: Baseline to 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease (PD)
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingObservational study
Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation
Parkinson Disease
Not yet recruiting
Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TB006 in people with Parkinson's Disease (PD), run by TrueBinding, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Parkinson's Disease Rating Scale Score (time frame: Baseline to 28 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.