Parkinson Disease (PD)Phase 1NCT07840027
Assessment of the Safety, Immunogenicity, and Pharmacodynamics of TRB-001 in Patients With Early Idiopathic Parkinson's Disease
A Phase 1 study testing TRB-001 in people with Parkinson Disease (PD) and Idiopathic Parkinson's Disease, run by Tridem Bioscience FlexCo at 1 site in Austria.
Trial summary
This is a randomized, placebo-controlled, double-blind, dose-finding phase 1b study with the purpose to assess the safety, immunogenicity and pharmacodynamics of TRB-001 in early idiopathic Parkinson's Disease patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease (PD), Idiopathic Parkinson's Disease
- What is being tested?
- TRB-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2026to Sep 2028
- Phase
- Phase 1
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male patients aged 40-75 years old. Refer to section 5.3 for reproductive criteria for male and female participants
- Diagnosed with idiopathic PD within the previous 4 years based on the MDS-PD criteria. The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present
- Severity ≤2 in the modified Hoehn and Yahr scale
- Brain magnetic resonance imaging (MRI) results should be consistent with the diagnosis of PD
- If on symptomatic PD medications (L-DOPA (+/- benserazide, carbidopa), COMT inhibitors (entacapone, opicapone), dopamine agonists (pramipexol, ropinirole, rotigotine, apomorphine), MAO-B inhibitors (safinamid, selegiline, rasagiline) or NMDA receptor antagonists (amantadine)), doses must be stable for at least 3 months before study entry
- Understands and agrees to comply with the study procedures and provides written informed consent
Who cannot join
- Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, or kanamycin, if considered relevant by the investigator
- Presence or history of autoimmune disease or immunodeficiency, if considered relevant by the investigator
- Presence of active infectious disease (hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
- Significant cognitive impairment or clinical dementia, or a Montreal Cognitive Assessment (MoCA) score <26
- High suspicion of other parkinsonian syndromes, such as multiple system atrophy, progressive supranuclear palsy, drug induced Parkinsonism and post-encephalitic Parkinsonism
- Any relevant systemic illness. This includes cardiovascular, hepatic, gastroenterological, respiratory, endocrinological, hematologic disease, or any other condition that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study, unless patient has been on stable doses of medication for any of these concurrent illnesses for at least 3 months prior to study entry
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- Unstable psychiatric illness, including psychosis, suicidal ideation, untreated major depression, schizophrenia, or bipolar affective disorder within 90 days before Visit 1, as determined by the investigator
- History of drug or alcohol abuse within the past 5 years
- Recent history (≤2 years) of cancer (exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
- Contraindication for MRI or lumbar puncture
- Female patients who are pregnant or lactating
- Birthmarks, tattoos, wounds, or skin conditions that may obscure the assessment of injection site reactions
- Participation in the active treatment phase of any non-PD clinical trial within 30 days prior to Visit 1
- Prior treatment with experimental immunotherapeutics for PD, immunosuppressive drugs or treatment with deep brain stimulation. Patient has received or plans to receive any vaccine other than study intervention within 28 days before or 28 days after each study vaccination.
- Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
PROSENEX Studienzentrum an der ATOMOS Klinik Währing
Vienna, 1180
Dieter Volc, +43664261660, dieter@volc.at
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Dose-finding Phase 1b Study to Assess the Safety, Immunogenicity and Pharmacodynamics of TRB-001 in Early Idiopathic Parkinson's Disease Patients
This is a randomized, placebo-controlled, double-blind, dose-finding phase 1b study with the purpose to assess the safety, immunogenicity and pharmacodynamics of TRB-001 in early idiopathic Parkinson's Disease patients.
- Being tested
- TRB-001, Placebo
- Keywords
- Early idiopathic Parkinson's Disease, Randomized Study, Placebo-controlled, double-blind, dose-finding, Phase 1b, immunogenicity, pharmacodynamics, Safety
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRB-001Biological
solution for intradermal injection
PlaceboOther
solution for intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| low dose (LD) | Experimental | 20 µg; 0.1 ml Receives: Biological: TRB-001; Other: Placebo |
| high dose (HD) | Experimental | 100 µg; 0.5 ml Receives: Biological: TRB-001; Other: Placebo |
| logarithmic dosing (LogD) | Experimental | 20, 40, and 100 µg; 0.1, 0.2, and 0.5 ml Receives: Biological: TRB-001; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate treatment-emergent adverse events at 2 different dose levels (LD, HD) compared to placebo in PD patients over 6 months (safety and tolerability of TRB-001)
Incidence of local and systemic treatment-emergent adverse events (TEAEs) (occurrence, intensity, duration, and relationship to IMPs) at LD and HD over 6 months (V1-V6) compared to placebo
Measured: 6 months
To assess immunogenicity of TRB-001 at 2 different dose levels (LD, HD) in PD patients over 6 months
Titers of anti-α-synuclein antibodies (immunizing peptide, α synuclein monomer) in blood samples at LD and HD over 6 months (V1-V6) compared to placebo as assessed by ELISA
Measured: 6 months
Secondary outcomes (4)
To investigate incidence of Treatment-Emergent Adverse Events compared to placebo in PD patients (Safety and Tolerability of TRB-001)
Incidence of local and systemic TEAEs at LogD over 6 months (V1-V6) compared to placebo Incidence of local and systemic TEAEs over 18 months (V1-V8) compared to placebo
Measured: 6 months 18 months
To assess immunogenicity of TRB-001 in PD patients
Titers of anti-α-synuclein antibodies (immunizing peptide, α synuclein monomer) in blood samples at LogD over 6 months (V1-V6) compared to placebo as assessed by ELISA
Measured: 6 months
To obtain liquid surrogate biomarkers of PD and evaluate their correlation with clinical activity
Measured: 6 months 18 months
To assess the efficacy of TRB-001 in delaying motor and non motor symptom progression compared to placebo in PD patients using MDS-UPDRS II (activity of daily life) and MDS-UPDRS III (motor-examination) over 18 months
Change from baseline in MDS-UPDRS II (activity of daily life) over 18 months (V2, V6-V8)
Change from baseline in MDS-UPDRS III (motor-examination) over 18 months (V2, V6-V8)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tridem Bioscience FlexCo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840027
- Sponsor's protocol ID
- TRB-PD-001
- Other IDs
- 2024-519123-14-00
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Dose-finding Phase 1b Study to Assess the Safety, Immunogenicity and Pharmacodynamics of TRB-001 in Early Idiopathic Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT07840027
- Acronym / sponsor ID
- TRB-PD-001
- Keywords
- Early idiopathic Parkinson's Disease, Randomized Study, Placebo-controlled, double-blind, dose-finding, Phase 1b, immunogenicity, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tridem Bioscience FlexCoIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 24 Sep 2026 (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.
This is a randomized, placebo-controlled, double-blind, dose-finding phase 1b study with the purpose to assess the safety, immunogenicity and pharmacodynamics of TRB-001 in early idiopathic Parkinson's Disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose (LD) | Experimental | Biological: TRB-001, Other: Placebo20 µg; 0.1 ml |
| high dose (HD) | Experimental | Biological: TRB-001, Other: Placebo100 µg; 0.5 ml |
| logarithmic dosing (LogD) | Experimental | Biological: TRB-001, Other: Placebo20, 40, and 100 µg; 0.1, 0.2, and 0.5 ml |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female or male patients aged 40-75 years old. Refer to section 5.3 for reproductive criteria for male and female participants
- Diagnosed with idiopathic PD within the previous 4 years based on the MDS-PD criteria. The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present
- Severity ≤2 in the modified Hoehn and Yahr scale
- Brain magnetic resonance imaging (MRI) results should be consistent with the diagnosis of PD
- If on symptomatic PD medications (L-DOPA (+/- benserazide, carbidopa), COMT inhibitors (entacapone, opicapone), dopamine agonists (pramipexol, ropinirole, rotigotine, apomorphine), MAO-B inhibitors (safinamid, selegiline, rasagiline) or NMDA receptor antagonists (amantadine)), doses must be stable for at least 3 months before study entry
Key exclusion criteria (15 listed)
- Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, or kanamycin, if considered relevant by the investigator
- Presence or history of autoimmune disease or immunodeficiency, if considered relevant by the investigator
- Presence of active infectious disease (hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
- Significant cognitive impairment or clinical dementia, or a Montreal Cognitive Assessment (MoCA) score <26
- High suspicion of other parkinsonian syndromes, such as multiple system atrophy, progressive supranuclear palsy, drug induced Parkinsonism and post-encephalitic Parkinsonism
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 |
|---|---|---|
| TRB-001solution for intradermal injection | Biological | high dose (HD), logarithmic dosing (LogD), low dose (LD) |
| Placebosolution for intradermal injection | Other | high dose (HD), logarithmic dosing (LogD), low dose (LD) |
Primary outcome
To investigate treatment-emergent adverse events at 2 different dose levels (LD, HD) compared to placebo in PD patients over 6 months (safety and tolerability of TRB-001)
Time frame: 6 months
Incidence of local and systemic treatment-emergent adverse events (TEAEs) (occurrence, intensity, duration, and relationship to IMPs) at LD and HD over 6 months (V1-V6) compared to placebo
To assess immunogenicity of TRB-001 at 2 different dose levels (LD, HD) in PD patients over 6 months
Time frame: 6 months
Titers of anti-α-synuclein antibodies (immunizing peptide, α synuclein monomer) in blood samples at LD and HD over 6 months (V1-V6) compared to placebo as assessed by ELISA
4 secondary outcomes
To investigate incidence of Treatment-Emergent Adverse Events compared to placebo in PD patients (Safety and Tolerability of TRB-001)
Time frame: 6 months 18 months
To assess immunogenicity of TRB-001 in PD patients
Time frame: 6 months
To obtain liquid surrogate biomarkers of PD and evaluate their correlation with clinical activity
Time frame: 6 months 18 months
To assess the efficacy of TRB-001 in delaying motor and non motor symptom progression compared to placebo in PD patients using MDS-UPDRS II (activity of daily life) and MDS-UPDRS III (motor-examination) over 18 months
Time frame: 18 months
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 24 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRB-001 in people with Parkinson Disease (PD) and Idiopathic Parkinson's Disease, run by Tridem Bioscience FlexCo at 1 site in Austria.
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 6 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact CEO Tridem (+4368120664069, office@tridem.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate treatment-emergent adverse events at 2 different dose levels (LD, HD) compared to placebo in PD patients over 6 months (safety and tolerability of TRB-001) (time frame: 6 months). The study lists 2 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 24 Sep 2026.