This is a first in human (FIH), single-centre, double -blind, randomised, cross-over, SAD followed by a MAD study of IZD334 conducted in healthy adult participants as well as an open-label cohort in adult patients with CAPS. The study is designed to evaluate the safety, tolerability, PK, PD, and food effect of IZD334 in healthy adult participants, and to evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of IZD334 in adult patients with CAPS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
64
Nucleus Network
Melbourne, Victoria, Australia
Incidence of treatment emergent adverse events [Safety and Tolerability]
Incidence, frequency and severity of treatment emergent adverse events.
Time frame: Day 1-8 for SAD
Incidence of treatment emergent adverse events [Safety and Tolerability]
Incidence, frequency and severity of treatment emergent adverse events.
Time frame: Day 1-16 for MAD
Peak plasma concentration (Cmax) single dose
Peak plasma concentration following single dose administration
Time frame: Day 1-3
Area under the plasma concentration versus time curve (AUC)- single dose
AUC following single dose administration
Time frame: Day 1-3
Peak Plasma Concentration (Cmax)-multiple dose
Peak plasma concentration following multiple dose administration
Time frame: Days 1-9
Area under the plasma concentration versus time curve (AUC)- multiple dose
AUC following multiple dose administration
Time frame: Days 1-9
Reduction of IL-1 production in stimulated whole blood
% reduction in IL-1 production in stimulated whole blood as measured by ELISA
Time frame: Day 1-3 for SAD and Day 1-9 for MAD]
Reduction in CAPS symptom scores
Reduction in Physician Assessed CAPS scores based on 8 point questionnaire
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Time frame: Day 1-15