Assessment of the Safety, Immunogenicity, and Pharmacodynamics of TRB-001 in Patients With Early Idiopathic Parkinson's Disease

NCT07840027 | Recruiting Phase 1 DMC

• 2 other identifiers: TRB-PD-0012024-519123-14-00
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease (PD); Idiopathic Parkinson's Disease

Keywords

Early idiopathic Parkinson's Disease; Randomized Study; Placebo-controlled; double-blind; dose-finding; Phase 1b; immunogenicity; pharmacodynamics; Safety

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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)

  6 months 18 months

• To assess immunogenicity of TRB-001 in PD patients

  6 months

• To obtain liquid surrogate biomarkers of PD and evaluate their correlation with clinical activity

  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

  18 months

Study Arms (3)

low dose (LD)

EXPERIMENTAL

20 µg; 0.1 ml

Biological: TRB-001; Other: Placebo

high dose (HD)

EXPERIMENTAL

100 µg; 0.5 ml

Biological: TRB-001; Other: Placebo

logarithmic dosing (LogD)

EXPERIMENTAL

20, 40, and 100 µg; 0.1, 0.2, and 0.5 ml

Biological: TRB-001; Other: Placebo

Interventions

TRB-001 BIOLOGICAL

solution for intradermal injection

high dose (HD); logarithmic dosing (LogD); low dose (LD)

Placebo OTHER

solution for intradermal injection

high dose (HD); logarithmic dosing (LogD); low dose (LD)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tridem Bioscience FlexCo: lead

Study Sites (1)

PROSENEX Studienzentrum an der ATOMOS Klinik Währing

Vienna, 1180, Austria

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

CEO Tridem

CONTACT

+4368120664069; office@tridem.at

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 24, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)