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.
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.