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.
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Incidence of treatment emergent adverse events [Safety and Tolerability]
Timeframe: Day 1-8 for SAD
Incidence of treatment emergent adverse events [Safety and Tolerability]
Timeframe: Day 1-16 for MAD
Peak plasma concentration (Cmax) single dose
Timeframe: Day 1-3
Area under the plasma concentration versus time curve (AUC)- single dose
Timeframe: Day 1-3
Peak Plasma Concentration (Cmax)-multiple dose
Timeframe: Days 1-9
Area under the plasma concentration versus time curve (AUC)- multiple dose
Timeframe: Days 1-9