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NCT07840027
Assessment of the Safety, Immunogenicity, and Pharmacodynamics of TRB-001 in Patients With Early Idiopathic Parkinson's Disease
Conditions: Parkinson Disease (PD), Idiopathic Parkinson's Disease
Sex: All
Ages: 40 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 36
Sponsor: Tridem Bioscience FlexCo
Location: PROSENEX Studienzentrum an der ATOMOS Klinik Währing Vienna
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.
Eligibility Criteria
Inclusion Criteria:
1. Female or male patients aged 40-75 years old. Refer to section 5.3 for reproductive criteria for male and female participants
2. 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
3. Severity ≤2 in the modified Hoehn and Yahr scale
4. Brain magnetic resonance imaging (MRI) results should be consistent with the diagnosis of PD
5. 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
6. Understands and agrees to comply with the study procedures and provides written informed consent
Exclusion Criteria:
1. Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, or kanamycin, if considered relevant by the investigator
2. Presence or history of autoimmune disease or immunodeficiency, if considered relevant by the investigator
3. Presence of active infectious disease (hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
4. Significant cognitive impairment or clinical dementia, or a Montreal Cognitive Assessment (MoCA) score \
Source: ClinicalTrials.gov (NCT07840027). StuddyBuddy aggregates publicly available trial information.