RecruitingPhase 1Phase 2NCT06310967

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


Sponsor

Intelligem Therapeutics Australia Pty Ltd.

Enrollment

60 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called IG3018 to lower uric acid levels in people with hyperuricemia (too much uric acid in the blood), which can cause gout and kidney problems. The trial includes both people with normal kidney function and those with moderate to advanced chronic kidney disease (CKD). **You may be eligible if...** - You are between 18 and 75 years old - You have elevated uric acid levels in your blood (above 0.48 mmol/L) - Part 1: You have normal or near-normal kidney function - Part 2: You have chronic kidney disease, stage 3a through 4 (moderate to severe CKD, but not yet on dialysis) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have severe heart, liver, or other serious medical conditions - You are currently taking certain other medications that interfere with the study drug - You are already on dialysis 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIG3018

Oral administration

OTHERPlacebo matching IG3018

Oral administration


Locations(6)

Emeritus Research Pty Ltd -Sydney

Botany, New South Wales, Australia

Pendlebury Research Pty Ltd T/A Novatrials

Kotara, New South Wales, Australia

Emeritus Research Pty Ltd -Melbourne

Camberwell, Victoria, Australia

Chung Shan Medical University Hospital

Taichung, Taiwan, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Chang Gung Memorial Hospital

Taoyuan, Taiwan, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06310967


Related Trials