Actively Recruiting
A Dose Escalation Study of IG3018 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
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 (inclusive).
- eGFR ≥ 60 mL/min/1.73 m² for subjects without CKD (Part 1).
- eGFR ≥ 15 and < 60 mL/min/1.73 m² for subjects with advanced predialysis CKD (Stage 3a, 3b, and 4) (Part 2).
- Fasting serum uric acid ≥ 0.48 mmol/L measured twice on different days or at end of run-in phase.
- Body Mass Index (BMI) between 18 and 35 kg/m² (inclusive).
- Female subjects of child-bearing potential must use highly effective contraception and abstain from egg donation from screening to 90 days after last dose; male partners must also use effective contraception.
- Fertile male subjects must not donate sperm and must use effective contraception from screening to 90 days after last dose; female partners must also use effective contraception.
- Able to understand and sign informed consent and comply with study procedures.
- For Part 2: Subjects with anemia requiring iron supplementation 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 before screening or less than 5 times the drug's half-life.
- Acute gout flares needing treatment within 4 weeks before or during screening.
- Major surgery within 3 months before first drug administration.
- History of malignant tumors within 6 months before screening.
- Recent serious cardiovascular or cerebrovascular events within 3 months.
- Use of other urate-lowering medications that cannot be stopped during study.
- Recent use or changes in drugs affecting serum uric acid within 1 month before screening.
- History of gastrointestinal surgery or severe GI diseases within specified time frames.
- Chronic use of parenteral nutrition including manganese within 3 months before screening.
- History or recent exposure to manganese toxicity.
- Inability to swallow oral medications.
- Recent treatment with investigational drugs or devices within 30 days before consent.
- Positive tests for HIV, syphilis, hepatitis B or C with specified viral loads.
- History of alcohol abuse or recent alcohol consumption within 48 hours before first dose.
- Uncontrolled hypertension or diabetes.
- Secondary hyperuricemia from tumors, blood diseases, drugs, or hereditary hyperuricemia.
- History or plan for kidney transplantation.
- Abnormal liver or biliary function or diseases beyond defined limits.
- History of serious allergic reaction to IG3018 components.
- Investigator judgment deeming participant unsuitable for study participation.
AI-Screening
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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
CONTACT
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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