This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of HL-400 (a NLRP3 inhibitor) following oral single and multiple ascending dose administration.
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Number and percentage of participants with adverse events (AEs)
Timeframe: From the time of taking first dose of study drug to 7 days after the last dose.
Number and percentage of adverse events (AEs) according to severity
Timeframe: From the time of taking first dose of study drug to 7 days after the last dose.
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
Timeframe: From baseline to 7 days after the last dose.
Single Ascending Dose (SAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400
Timeframe: From 0.5 hour to 72 hours post-dose.
Single Ascending Dose (SAD) Cohorts: Time to reach maximum observed plasma concentration (Tmax) of HL-400
Timeframe: From 0.5 hour to 72 hours post-dose.
Single Ascending Dose (SAD) Cohorts: Plasma decay half-life (t1/2) of HL-400
Timeframe: From 0.5 hour to 72 hours post-dose.
Single Ascending Dose (SAD) Cohorts: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400
Timeframe: From 0.5 hour to 72 hours post-dose.
Multiple Ascending Dose (MAD) Cohorts: Maximum observed plasma concentration (Cmax) of HL-400
Timeframe: From Day 1 pre-dose to 72 hours after the last dose.
Multiple Ascending Dose (MAD) Cohorts: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of HL-400
Timeframe: From Day 1 pre-dose to 72 hours after the last dose.