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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
PROSENEX Studienzentrum an der ATOMOS Klinik Währing
Vienna, Austria
RECRUITINGTo 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
Time frame: 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
Time frame: 6 months
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
Time frame: 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
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
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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Time frame: 18 months