RecruitingPhase 1NCT06997484

First-in-Human Single and Multiple Dose of HL-400

A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single and Multiple Ascending Dose (SAD/MAD) Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics of HL-400 Following Oral Administration

Sponsor

Highlightll Pharmaceutical (USA) LLC

Enrollment

86 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human safety study of a new investigational drug called HL-400, testing it in healthy volunteers to learn how the body processes it, what doses are safe, and whether it causes any side effects. This is the first step before the drug is tested in patients with disease. **You may be eligible if...** - You are between 18 and 65 years old - You are considered generally healthy, with no significant medical conditions - You have not smoked for at least 6 months - Your BMI is between 18 and 32, and you weigh at least 50 kg - You are willing to follow all dietary and study requirements **You may NOT be eligible if...** - You have a significant history of heart, liver, kidney, gastrointestinal, or psychiatric disease - You are pregnant or breastfeeding - You test positive for HIV, hepatitis B, or hepatitis C - You test positive for alcohol or drugs at screening - You have taken part in another drug study in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHL-400

Part 1:Experimental: Single oral dose of HL-400, Single ascending doses, sequential assignment group design; Part 2: Experimental: Multiple oral doses of HL-400, Multiple ascending doses, QD for 14 days, sequential assignment group design; Part 3: Experimental: Multiple oral doses of HL-400, QD for 5 days.

DRUGPlacebo

Part 1: Placebo comparator: Single oral dose of placebo, single doses, matching placebo; Part 2: Placebo comparator: Multiple oral doses of placebo, multiple ascending doses, QD for 14 days, matching placebo.