Study of IG3018 Tablets to Assess Safety, Effectiveness, and Body Processing in Adults with High Uric Acid Levels, With or Without Chronic Kidney Disease

What this Trial Is About

Researchers are investigating the safety, tolerability, pharmacokinetics, and effectiveness of the drug IG3018 in people with high uric acid levels hyperuricemia, including those with and without chronic kidney disease CKD. This phase III clinical trial aims to better understand how IG3018 works in these groups and to explore appropriate dosing. The study is sponsored by Intelligem Therapeutics Australia Pty Ltd and includes participants aged 18 to 75 years. The trial has two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation study in participants without CKD, testing increasing doses of IG3018 tablets 0.25 g, 0.5 g, and 1.0 g. Each dose cohort receives a single dose followed by four weeks of twice-daily maintenance dosing. Part 2 is an open-label study in participants with advanced predialysis CKD Stages 3a, 3b, and 4, who receive either 0.5 g or 1.0 g of IG3018 twice daily for four weeks. Participants will attend study visits for blood and urine sample collection to analyze drug levels and kidney function. Safety and efficacy will be assessed through laboratory tests, gout attack monitoring, and uric acid measurements over about 46 days. The study tracks changes in serum uric acid levels, kidney function markers, and drug pharmacokinetics. Participants must provide consent and follow study procedures throughout the treatment and monitoring periods.

A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease