HyperuricemiaPhase 1/2NCT06310967
A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease
A Phase 1/2 study testing IG3018 in people with Hyperuricemia and Hypouricemia, Renal, run by Intelligem Therapeutics Australia Pty Ltd. at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperuricemia, Hypouricemia, Renal
- What is being tested?
- IG3018
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 12 Nov 2024to Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Part 1 and Part 2:
- Subjects must meet all the following criteria to be included in the study:
- Male or female, aged 18 to 75 years (both inclusive).
- 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.
- The serum uric acid level for subjects need to meet any of the following:
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- 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.
- Body Mass Index (BMI) ≥ 18 and ≤ 35 kg/m2 (both inclusive) at screening.
- 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.
- Male subjects considered fertile must agree to not donate sperm, and take effective contraceptive methods from the screening phase to 90 days after the last dose of the IMP. And the female partner of male subjects also needs to agree to use a highly effective method of female contraception during this phase.
- Able to understand and give signed written informed consent form (ICF) and willing to comply with all study procedures.
- Only for Part 2
- For subjects with anemia who require iron supplementation, steady iron or iron-containing drugs should be used for at least 3 months, and the original treatment regimen should be maintained during the study period.
Who cannot join
- For Part 1 and Part 2:
- Subjects who meet any of the following criteria will be excluded from the study:
- 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).
- Subjects who have acute gout flares requiring treatment within 4 weeks prior to or during screening.
- Major surgery within 3 months prior to the first administration.
- History of malignant tumors within 6 months prior to screening.
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- 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.
- 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.
- 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.
- 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.
- History of GI diseases, including gastrointestinal bleeding moderate to severe gastrointestinal dysfunction, moderate to severe chronic constipation for a minimum of 3 months prior to screening, or newly diagnosed peptic or duodenal ulcer diseases within 4 weeks prior to screening.
- Chronic use of parenteral nutrition including manganese within 3 months prior to screening.
- Subjects who have the history of manganese toxicity or excessive exposure to manganese (i.e., having worked in a mine, foundry, smelter, dry cell battery manufacturing facility) within 2 months prior to screening.
- Inability to swallow oral medications.
- Received treatment with or exposure to an investigational drug or device within 30 days of signing informed consent.
- Subjects with one of positive results of HIV virus or syphilis, or positive hepatitis B virus surface antigen (HBsAg) and the number of copies of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU/mL (or 2500 copies, or the lower limit of the positive detection value of the study site) at screening, or HBsAg (-), hepatitis B core antibody (HBcAb) (+) and the number of copies of HBV DNA ≥ 500 IU/mL (or 2500 copies, or the lower limit of the positive detection value of the study site) after treatment of HBV infection, or positive hepatitis C antibody (HCV-Ab), and hepatitis C virus (HCV) ribonucleic acid (RNA) ≥upper limit of normal (ULN) of the study site during screening phase.
- History of alcohol abuse, or subjects who consumed alcohol within 48 h before the first administration or did not agree to stop using alcohol products during the study.
- Subjects who have previously been diagnosed with the following diseases and have not been able to control them after medication therapy or other treatment. Uncontrolled is defined as hypertension: sSBP ≥ 180 mmHg and/or sDBP ≥ 110 mmHg; or Diabetes mellitus: HbA1c ≥ 9% at screening.
- Subjects with secondary hyperuricemia caused by tumor, hematological system diseases, drugs, etc. except for chronic kidney disease; or hereditary hyperuricemia at screening.
- Subjects undergone kidney transplantation or planning to undergo kidney transplantation at screening.
- Subjects with abnormal biliary function, biliary obstruction, or biliary gallstone at screening; Subjects with alanine aminotransferase (ALT) ≥3 ULN, aspartate aminotransferase (AST)≥3 ULN, or total bilirubin (TBIL) ≥1.5 ULN at screening.
- Prior or current cholestatic liver disease defined as a clinical condition associated with decrease in bile flow due to impaired secretion by hepatocytes or to obstruction of bile flow through intra-or extrahepatic bile ducts.
- History of serious hypersensitivity reaction to a known ingredient of IG3018 tablet judged by the investigator.
- Subjects who are considered unsuitable for participating in the study in the opinion of the investigator judgment.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Australia3 sites, 3 recruiting
- Recruiting
Emeritus Research Pty Ltd -Sydney
Botany, New South Wales, 2019
Paul A Bird, PhD, +61 2 8964 8186, paulbird@emeritusresearch.com
- Recruiting
Emeritus Research Pty Ltd -Melbourne
Camberwell, Victoria, 3124
Paul A Bird, PhD, +61 2 8964 8186, paulbird@emeritusresearch.com
- Recruiting
Pendlebury Research Pty Ltd T/A Novatrials
Kotara, New South Wales, 2289
Oscar M Cumming, Med Bachelor, +61 2 4089 3744, oscar@novatrials.com.au
Taiwan3 sites, 3 recruiting
- Recruiting
Chung Shan Medical University Hospital
Taichung, Taiwan, 402306
Cheng-Chung Wei, Professor, +886-4-24739595, wei3228@gmail.com
- Recruiting
Taipei Medical University Hospital
Taipei, Taiwan, 110301
Tzu-Min Lin, Attending physician, +886-2- 27372181, chateauxjolie@yahoo.com.tw
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333423
Chang-Fu Kuo, Professor, +886-3- 3281200, zandis@gmail.com
About this study
Official title: A Dose Escalation Study of IG3018 to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics in Subjects With Hyperuricemia With or Without Chronic Kidney Disease
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.
Read the 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
- Being tested
- IG3018, Placebo matching IG3018
- Keywords
- Hyperuricemia, Renal, Hyperuricemia, Chronic Kidney Disease, CKD, Hyperuricemia, CKD
- Medical subject headings
- Hyperuricemia, Renal hypouricemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IG3018Drug
Oral administration
Placebo matching IG3018Other
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (0.25 g tablets) | Other | Cohort A will have 10 eligible patients. 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort.
Dose shall be at 0.25 g tablets. Single-dose initial treatment phase: D1~D3. Subject will receive a single dose of IG3018 or the placebo on Day 1. The predetermined information shall be collected in the form of blood and urine samples for PK analyses, whilst efficacy and safety assessment data will be collected within 48 hours after the single dose of study drug administration (IG3018 or placebo).
Maintenance treatment on daily basis phase: 4 weeks. Subjects in this maintenance treatment phase shall receive the study drug IG3018 in twice daily dosing for 28 days from Day 4 to Day 31, and will be given IG3018 once on the morning of D32. Receives: Drug: IG3018; Other: Placebo matching IG3018 |
| Cohort B (0.5 g tablets) | Other | Cohort B will have 10 eligible patients. 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort.
Dose shall be at 0.5 g tablets. Single-dose initial treatment phase: D1~D3. Subject will receive a single dose of IG3018 or the placebo on Day 1. The predetermined information shall be collected in the form of blood and urine samples for PK analyses, whilst efficacy and safety assessment data will be collected within 48 hours after the single dose of study drug administration (IG3018 or placebo).
Maintenance treatment on daily basis phase: 4 weeks. Subjects in this maintenance treatment phase shall receive the study drug IG3018 in twice daily dosing for 28 days from Day 4 to Day 31, and will be given IG3018 once on the morning of D32. Receives: Drug: IG3018; Other: Placebo matching IG3018 |
| Cohort C (1.0 g tablets) | Other | Cohort C will have 10 eligible patients. 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort.
Dose shall be at 1.0 g tablets. Single-dose initial treatment phase: D1~D3. Subject will receive a single dose of IG3018 or the placebo on Day 1. The predetermined information shall be collected in the form of blood and urine samples for PK analyses, whilst efficacy and safety assessment data will be collected within 48 hours after the single dose of study drug administration (IG3018 or placebo).
Maintenance treatment on daily basis phase: 4 weeks. Subjects in this maintenance treatment phase shall receive the study drug IG3018 in twice daily dosing for 28 days from Day 4 to Day 31, and will be given IG3018 once on the morning of D32. Receives: Drug: IG3018; Other: Placebo matching IG3018 |
| Cohort D (0.5 g BID IG3018) | Other | 12 to 15 hyperuricemia subjects with advanced predialysis CKD (at least 6 Taiwanese subjects are required) will be enrolled in Cohort D and will receive 0.5 g IG3018 twice daily (BID) for 4 weeks. Receives: Drug: IG3018 |
| Cohort E (1.0 g BID IG3018) | Other | 12 to 15 hyperuricemia subjects with advanced predialysis CKD (at least 6 Taiwanese subjects are required) will be enrolled in Cohort E and will receive 1.0 g IG3018 twice daily (BID) for 4 weeks. Receives: Drug: IG3018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessments (Part 1 and Part 2)
Safety as assessed by incidence of reported adverse events, clinically significant changes in vital signs, physical examination, laboratory tests, 12-lead ECG.
Safety as assessed by incidence of AEs by using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5).
Measured: Baseline through study completion at up to 46 days
The proportions of change from baseline in serum uric acid to normal level (≤ 0.36 mmol/L) (Part 1 and Part 2)
The proportions of change from baseline in serum uric acid to normal level (≤ 0.36 mmol/L) following 4 weeks treatment with IG3018 in each dose.
Measured: 4 weeks
Secondary outcomes (13)
The proportions of change from baseline in serum uric acid to ≤ 0.30 mmol/L and ≤ 0.24 mmol/L respectively (Part 1 and Part 2)
The proportions of change from baseline in serum uric acid to ≤ 0.30 mmol/L and ≤ 0.24 mmol/L respectively, following 4 weeks treatment with IG3018 in each dose.
Measured: 4 weeks
The actual change of serum uric acid (Part 1 and Part 2)
The actual change of serum uric acid from baseline to the end of 1, 2, 3, and 4 weeks of each treatment group.
Measured: 4 weeks
The percentage change of serum uric acid (Part 1 and Part 2)
The percentage change of serum uric acid from baseline to the end of 1, 2, 3, and 4 weeks of each treatment group.
Measured: 4 weeks
Gouty Attacks (Part 1 and Part 2)
Incidence of reported gouty attacks during the study period.
Measured: Baseline through study completion at up to 46 days
Urinary Albumin/Creatinine Ration (U-ACR) (Part 2 only)
The change in Urinary Albumin/Creatinine ration (U-ACR) during the study period.
Measured: Baseline through study completion at up to 43 days
Ae of IG3018 (Part 1 only)
Urine Accumulative excretion (Ae) of IG3018
Measured: 32 days
Cmax of IG3018 (Part 1 only)
Maximum observed whole blood concentration of IG3018
Measured: 46 days
Tmax of IG3018 (Part 1 only)
Time to reach maximum whole blood concentration of IG3018
Measured: 46 days
T1/2 of IG3018 (Part 1 only)
Terminal half-life of IG3018
Measured: 46 days
Estimated glomerular filtration rate (eGFR) (Part 2 only)
The change in estimated glomerular filtration rate (eGFR) during the study period.
Measured: Baseline through study completion at up to 43 days
Cmax of IG3018 (Part 2 Taiwanese subjects only)
Maximum observed whole blood concentration of IG3018
Measured: 43 days
Tmax of IG3018 (Part 2 Taiwanese subjects only)
Time to reach maximum whole blood concentration of IG3018
Measured: 43 days
T1/2 of IG3018 (Part 2 Taiwanese subjects only)
Terminal half-life of IG3018
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start12 Nov 2024
- Primary completionJul 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1 is a randomized, double-blind, placebo-controlled study where the doses of the study drug are escalated in a predesigned manner in 3 cohorts. 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. Each cohort will have 10 eligible patients. Randomization will be performed in Part 1 and as per the randomization code, 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort. A total of 30 subjects are planned to be enrolled. Part 2 is an open-label PoC study involving hyperuricemia subjects with advanced predialysis CKD (Stage 3a, Stage 3b and Stage 4), and treated with two doses of IG3018 \[0.5 g BID (Cohort D) and 1.0 g BID (Cohort E)\]. 12 to 15 hyperuricemia subjects with advanced predialysis CKD (at least 6 Taiwanese subjects are required) will be enrolled in each dose and will receive the determined study dose of IG3018 BID for 4 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intelligem Therapeutics Australia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310967
- Sponsor's protocol ID
- IG3018-23-02-01
- Status last verified
- Feb 2026
- First submitted
- 3 Mar 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Study of IG3018 to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics in Subjects With Hyperuricemia With or Without Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06310967
- Acronym / sponsor ID
- IG3018-23-02-01
- Conditions
- Hyperuricemia, Hypouricemia, Renal
- Keywords
- Hyperuricemia, Renal, Hyperuricemia, Chronic Kidney Disease, CKD, Hyperuricemia, CKD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Intelligem Therapeutics Australia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Part 1 is a randomized, double-blind, placebo-controlled study where the doses of the study drug are escalated in a predesigned manner in 3 cohorts. 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. Each cohort will have 10 eligible patients. Randomization will be performed in Part 1 and as per the randomization code, 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort. A total of 30 subjects are planned to be enrolled. Part 2 is an open-label PoC study involving hyperuricemia subjects with advanced predialysis CKD (Stage 3a, Stage 3b and Stage 4), and treated with two doses of IG3018 [0.5 g BID (Cohort D) and 1.0 g BID (Cohort E)]. 12 to 15 hyperuricemia subjects with advanced predialysis CKD (at least 6 Taiwanese subjects are required) will be enrolled in each dose and will receive the determined study dose of IG3018 BID for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Cohort A (0.25 g tablets) | Other | Drug: IG3018, Other: Placebo matching IG3018Cohort A will have 10 eligible patients. 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort. Dose shall be at 0.25 g tablets. Single-dose initial treatment phase: D1~D3. Subject will receive a single dose of IG3018 or the placebo on Day 1. The predetermined information shall be collected in the form of blood and urine samples for PK analyses, whilst efficacy and safety assessment data will be collected within 48 hours after the single dose of study drug administration (IG3018 or placebo). Maintenance treatment on daily basis phase: 4 weeks. Subjects in this maintenance treatment phase shall receive the study drug IG3018 in twice daily dosing for 28 days from Day 4 to Day 31, and will be given IG3018 once on the morning of D32. |
| Cohort B (0.5 g tablets) | Other | Drug: IG3018, Other: Placebo matching IG3018Cohort B will have 10 eligible patients. 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort. Dose shall be at 0.5 g tablets. Single-dose initial treatment phase: D1~D3. Subject will receive a single dose of IG3018 or the placebo on Day 1. The predetermined information shall be collected in the form of blood and urine samples for PK analyses, whilst efficacy and safety assessment data will be collected within 48 hours after the single dose of study drug administration (IG3018 or placebo). Maintenance treatment on daily basis phase: 4 weeks. Subjects in this maintenance treatment phase shall receive the study drug IG3018 in twice daily dosing for 28 days from Day 4 to Day 31, and will be given IG3018 once on the morning of D32. |
| Cohort C (1.0 g tablets) | Other | Drug: IG3018, Other: Placebo matching IG3018Cohort C will have 10 eligible patients. 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort. Dose shall be at 1.0 g tablets. Single-dose initial treatment phase: D1~D3. Subject will receive a single dose of IG3018 or the placebo on Day 1. The predetermined information shall be collected in the form of blood and urine samples for PK analyses, whilst efficacy and safety assessment data will be collected within 48 hours after the single dose of study drug administration (IG3018 or placebo). Maintenance treatment on daily basis phase: 4 weeks. Subjects in this maintenance treatment phase shall receive the study drug IG3018 in twice daily dosing for 28 days from Day 4 to Day 31, and will be given IG3018 once on the morning of D32. |
| Cohort D (0.5 g BID IG3018) | Other | Drug: IG301812 to 15 hyperuricemia subjects with advanced predialysis CKD (at least 6 Taiwanese subjects are required) will be enrolled in Cohort D and will receive 0.5 g IG3018 twice daily (BID) for 4 weeks. |
| Cohort E (1.0 g BID IG3018) | Other | Drug: IG301812 to 15 hyperuricemia subjects with advanced predialysis CKD (at least 6 Taiwanese subjects are required) will be enrolled in Cohort E and will receive 1.0 g IG3018 twice daily (BID) for 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, aged 18 to 75 years (both inclusive).
- 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.
- 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.
Key exclusion criteria (24 listed)
- 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).
- Subjects who have acute gout flares requiring treatment within 4 weeks prior to or during screening.
- Major surgery within 3 months prior to the first administration.
- History of malignant tumors within 6 months prior to screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IG3018Oral administration | Drug | Cohort A (0.25 g tablets), Cohort B (0.5 g tablets), Cohort C (1.0 g tablets), Cohort D (0.5 g BID IG3018), Cohort E (1.0 g BID IG3018) |
| Placebo matching IG3018Oral administration | Other | Cohort A (0.25 g tablets), Cohort B (0.5 g tablets), Cohort C (1.0 g tablets) |
Primary outcome
Safety Assessments (Part 1 and Part 2)
Time frame: Baseline through study completion at up to 46 days
Safety as assessed by incidence of reported adverse events, clinically significant changes in vital signs, physical examination, laboratory tests, 12-lead ECG. Safety as assessed by incidence of AEs by using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5).
The proportions of change from baseline in serum uric acid to normal level (≤ 0.36 mmol/L) (Part 1 and Part 2)
Time frame: 4 weeks
The proportions of change from baseline in serum uric acid to normal level (≤ 0.36 mmol/L) following 4 weeks treatment with IG3018 in each dose.
13 secondary outcomes
The proportions of change from baseline in serum uric acid to ≤ 0.30 mmol/L and ≤ 0.24 mmol/L respectively (Part 1 and Part 2)
Time frame: 4 weeks
The actual change of serum uric acid (Part 1 and Part 2)
Time frame: 4 weeks
The percentage change of serum uric acid (Part 1 and Part 2)
Time frame: 4 weeks
Gouty Attacks (Part 1 and Part 2)
Time frame: Baseline through study completion at up to 46 days
Urinary Albumin/Creatinine Ration (U-ACR) (Part 2 only)
Time frame: Baseline through study completion at up to 43 days
Ae of IG3018 (Part 1 only)
Time frame: 32 days
Cmax of IG3018 (Part 1 only)
Time frame: 46 days
Tmax of IG3018 (Part 1 only)
Time frame: 46 days
T1/2 of IG3018 (Part 1 only)
Time frame: 46 days
Estimated glomerular filtration rate (eGFR) (Part 2 only)
Time frame: Baseline through study completion at up to 43 days
Cmax of IG3018 (Part 2 Taiwanese subjects only)
Time frame: 43 days
Tmax of IG3018 (Part 2 Taiwanese subjects only)
Time frame: 43 days
T1/2 of IG3018 (Part 2 Taiwanese subjects only)
Time frame: 43 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IG3018 in people with Hyperuricemia and Hypouricemia, Renal, run by Intelligem Therapeutics Australia Pty Ltd. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Operation Team (+8610 53688632, clinicaltrials@intelligemtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessments (Part 1 and Part 2) (time frame: Baseline through study completion at up to 46 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.