Single center, open-label, intra-individual dose-escalation study in subjects with mild/moderate Parkinson's Disease
After assessing eligibility during a screening period of up to 4 weeks, up to 6 subjects will be included. Subjects will check into the clinic one day prior to dosing (Day -1). To evaluate and compare drug exposure levels in plasma and CSF, plasma and CSF will be serially sampled over a period of 36 hours. Subjects will be discharged from the clinic on Day 5 after all required study procedures are completed and if medically justified. Subjects will return to the clinic approximately 1 week after discharge from the clinic for a follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Small molecule inhibitor of NLRP3
Concentration of IZD174 in plasma
Plasma PK profile following an intra-individual dose escalation of IZD174
Time frame: Pre-dose to 36 hours post dose
Concentration of IZD174 in cerebrospinal fluid
CSF PK profile following an intra-individual dose escalation of IZD174
Time frame: Pre-dose to 36 hours post dose
Ratio of IZD174 concentration in plasma to CSF
CSF to plasma concentration ratio at each time point
Time frame: Pre-dose to 36 hours post dose
Inhibition of Interleukin-1 beta secretion in ex-vivo stimulated whole blood
Inhibition of IL-1 secretion by ex-vivo stimulated whole blood
Time frame: Pre-dose to 36 hours post dose
Incidence of Treatment-Emergent Adverse Events
Safety \& Tolerability as measured by incidence if Treatment-Emergent Adverse events
Time frame: Day 0 to Day 10
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