NCT06310967

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

A Dose Escalation Study of IG3018 to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics in Subjects With Hyperuricemia With or Without Chronic Kidney Disease

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Intelligem Therapeutics Australia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II clinical study to evaluate the safety, tolerability, PK, and efficacy of IG3018 tablet in hyperuricemia (HUA) subjects with or without CKD.

Detailed description

The study has two parts: Part 1 is a randomized, double-blind, placebo-controlled, dose escalation study in hyperuricemia subjects without CKD. Initiation Dose shall be at 0.25 g tablets (Cohort A) and doses are escalated to 0.5 g (Cohort B) and then to 1.0 g (Cohort C) in a planned manner. Part 2 is an open-label, proof of concept study involving hyperuricemia subjects with advanced predialysis CKD (Stage 3a, Stage 3b and Stage 4), and treated with two doses \[0.5 g BID IG3018 (Cohort D) and 1.0 g BID IG3018 (Cohort E)\].

Conditions

• Hyperuricemia
• Hypouricemia, Renal

Interventions

Type	Name	Description
DRUG	IG3018	Oral administration
OTHER	Placebo matching IG3018	Oral administration

Timeline

• Start date: 2024-11-12
• Primary completion: 2026-07-01
• Completion: 2027-01-01
• First posted: 2024-03-15
• Last updated: 2026-02-03

Locations

6 sites across 2 countries: Australia, Taiwan