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A Dose Escalation Study of IG3018 to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics in Subjects With Hyperuricemia With or Without Chronic Kidney Disease
Led by Intelligem Therapeutics Australia Pty Ltd. · Updated on 2026-02-03
60
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
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 I/II 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.
CONDITIONS
Brief Title
A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 to 75 years (both inclusive)
- For Part 1: No chronic kidney disease with eGFR ≥ 60 mL/min/1.73 m2 at screening
- For Part 2: Advanced predialysis chronic kidney disease (Stage 3a, 3b, or 4) with eGFR ≥15 and <60 mL/min/1.73 m2 at screening
- Serum uric acid level ≥ 0.48 mmol/L at screening or end of run-in phase
- Body Mass Index (BMI) between 18 and 35 kg/m2 (both inclusive) at screening
- Female subjects of child-bearing potential must use effective contraception from screening to 90 days after last dose; male partners must also use contraception
- Male fertile subjects must agree to effective contraception from screening to 90 days after last dose; female partners must also use contraception
- Able to understand and provide signed informed consent and comply with study procedures
- For Part 2 only: If anemic requiring iron supplements, must have stable treatment for at least 3 months and maintain regimen during study
You will not qualify if you...
- Prior uricase or recombinant uricase therapy within 2 weeks or less than 5 times the drug half-life before screening
- Acute gout attacks requiring treatment within 4 weeks before or during screening
- Major surgery within 3 months prior to first dose
- History of cancer within 6 months prior to screening
- Recent cardiovascular or cerebrovascular events within 3 months prior to screening
- Use of other urate-lowering drugs that cannot be stopped during study
- Use or changes of drugs affecting uric acid levels within 1 month before screening
- History of gastrointestinal surgery or serious GI diseases before screening
- Chronic use of parenteral nutrition including manganese within 3 months before screening
- History or exposure to manganese toxicity within 2 months before screening
- Unable to swallow oral medications
- Treatment or exposure to investigational drugs/devices within 30 days before consent
- Positive tests for HIV, syphilis, or hepatitis B or C with active infection levels at screening
- History of alcohol abuse or alcohol use within 48 hours before first dose
- Uncontrolled hypertension or diabetes at screening
- Secondary hyperuricemia caused by certain diseases or hereditary hyperuricemia
- Previous or planned kidney transplantation at screening
- Abnormal biliary function or liver tests above specified limits
- Prior or current cholestatic liver disease
- Serious allergic reaction to IG3018 ingredients
- Considered unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 5 weeks
Participants receive IG3018 or placebo starting with a single dose on Day 1 followed by maintenance dosing twice daily for 28 days, with an additional dose on the morning of Day 32.
Single-dose initial treatment phase for 3 days followed by daily dosing for 28 days and one additional dose on Day 32
Duration - Up to 2 weeks after treatment
Safety, efficacy, and pharmacokinetic assessments continue through study completion up to 46 days from baseline.
Visits for safety and efficacy monitoring up to Day 46
Trial Site Locations
Total: 6 locations
1
Emeritus Research Pty Ltd -Sydney
Botany, New South Wales, Australia, 2019
Actively Recruiting
2
Pendlebury Research Pty Ltd T/A Novatrials
Kotara, New South Wales, Australia, 2289
Actively Recruiting
3
Emeritus Research Pty Ltd -Melbourne
Camberwell, Victoria, Australia, 3124
Actively Recruiting
4
Chung Shan Medical University Hospital
Taichung, Taiwan, Taiwan, 402306
Actively Recruiting
5
Taipei Medical University Hospital
Taipei, Taiwan, Taiwan, 110301
Actively Recruiting
6
Chang Gung Memorial Hospital
Taoyuan, Taiwan, Taiwan, 333423
Actively Recruiting
Research Team
O
Operation Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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