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A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT06310967•Intelligem Therapeutics Australia Pty Ltd.

View on ClinicalTrials.gov

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 \[0.5 g BID IG3018 (Cohort D) and 1.0 g BID IG3018 (Cohort E)\].

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For Part 1 and Part 2:
•Subjects must meet all the following criteria to be included in the study:
•1. Male or female, aged 18 to 75 years (both inclusive).
•2. According to the investigator's judgment, eGFR must be met as:
•Part 1 only: subjects without CKD and have eGFR ≥ 60 mL/minute/1.73 m2 at screening phase; Part 2 only: subjects with advanced predialysis CKD (Stage 3a, 3b and Stage 4) have eGFR≥15 and \<60 mL/minute/1.73 m2 at screening phase.
•3. The serum uric acid level for subjects need to meet any of the following:
•For subjects already on ULT within 2 weeks prior to the screening visit, the serum uric acid would be measured during the screening visit/phase, and then at the end of the run-in phase, prior to confirming their eligibility. Subjects with ULT within 2 weeks before screening has fasting serum uric acid ≥ 0.48 mmol/L at the end of run-in phase.
•For subjects without ULT in 2 weeks prior to screening visit，the serum uric acid should be measured twice on 2 different days (at least 24 hours apart) prior to confirming their eligibility. Subjects without ULT within 2 weeks before screening has fasting serum uric acid ≥ 0.48 mmol/L at screening phase.
•4. Body Mass Index (BMI) ≥ 18 and ≤ 35 kg/m2 (both inclusive) at screening.
•5. Female subjects of child-bearing potential \[defined as women who have experienced menarche but have not reached postmenopausal status (defined as at least 12 consecutive months of amenorrhea without any other identifiable cause other than menopause), and who have not undergone surgery (i.e., bilateral oophorectomy and/or bilateral salpingectomy and/or hysterectomy) or have no other cause of permanent infertility as determined by the investigator (e.g., Müllerian agenesis).\] must agree to use highly effective contraceptive methods and must abstain from egg collection or donation from the screening phase to 90 days after the last dose of the IMP. And the male partner of a female subject also needs to agree to use highly effective method of birth control during this phase.
+4 more criteria

Exclusion Criteria

•For Part 1 and Part 2:
•Subjects who meet any of the following criteria will be excluded from the study:
•1. Prior uricase/recombinant uricase (such as Rasburicase or Pegloticase) therapy within 2 weeks prior to screening or last dose of therapy\< 5 times the half-life (whichever is longer).
•2. Subjects who have acute gout flares requiring treatment within 4 weeks prior to or during screening.
•3. Major surgery within 3 months prior to the first administration.
•4. History of malignant tumors within 6 months prior to screening.
•5. Subjects within the last 3 months have: myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemia attack.
•6. Subjects who are on other urate-lowering medication (allopurinol, febuxostat, probenecid and benzbromarone) and cannot stop during the study periods included in the run-in phase.
•7. Subject with underlying medical conditions requiring changes or introduction of drugs that have the potential impact on the serum uric acid levels (e.g., salicylic acids, diuretics, angiotensin receptor blockers, etc.) within at least 1 month prior the screening phase.
•8. History of gastrointestinal (GI) surgery, including gastric sleeve, colostomy/enterostomy, Roux-en-Y or gastric banding (unless gastric band removed for a minimum of 12 months prior to screening.
+14 more criteria

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 District, Taiwan, Taiwan

Key Dates

Start Date

November 12, 2024

Primary Completion Date

July 1, 2026

Completion Date

January 1, 2027

Last Updated

February 3, 2026

Enrollment

ESTIMATED participants

Conditions

HyperuricemiaHypouricemia, Renal

Interventions

IG3018

DRUG

Placebo matching IG3018

OTHER

Contacts

Operation Team

CONTACT

+8610 53688632 clinicaltrials@intelligemtx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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