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.
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
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
Sequential
TRB-001
Biological/Vaccinesolution for intradermal injection
Placebo
Other interventionsolution for intradermal injection
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
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
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
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
To obtain liquid surrogate biomarkers of PD and evaluate their correlation with clinical activity
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)
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