This is a first in human (FIH), single-centre, double blind, randomised, cross-over, SAD followed by a MAD study of Inzomelid. The study is designed to evaluate the safety, tolerability, PK, PD, and food effect of Inzomelid in healthy adult participants and to evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of Inzomelid in adult patients with CAPS. Oversight will be provided by a safety monitoring committee (SMC) comprised of the Investigator, the Sponsor's Medical Monitor and an Independent Medical Monitor.
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Incidence of treatment emergent advert events [Safety and Tolerability]
Timeframe: Day 1-8 for SAD, 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
Peak Plasma Concentration (Cmax)-multiple dose
Timeframe: Days 1-16
Area under the plasma concentration versus time curve (AUC)- multiple dose
Timeframe: Days 1-16