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

NCT06310967 | Recruiting Phase 1

• 1 other identifier: IG3018-23-02-01
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Hyperuricemia; Hypouricemia, Renal

Keywords

Hyperuricemia, Renal; Hyperuricemia; Chronic Kidney Disease; CKD; Hyperuricemia, CKD

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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)

  4 weeks

• The actual change of serum uric acid (Part 1 and Part 2)

  4 weeks

• The percentage change of serum uric acid (Part 1 and Part 2)

  4 weeks

• Gouty Attacks (Part 1 and Part 2)

  Baseline through study completion at up to 46 days

• Urinary Albumin/Creatinine Ration (U-ACR) (Part 2 only)

  Baseline through study completion at up to 43 days

Study Arms (5)

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.

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.

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.

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.

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.

Drug: IG3018

Interventions

IG3018 DRUG

Oral administration

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 IG3018 OTHER

Oral administration

Cohort A (0.25 g tablets); Cohort B (0.5 g tablets); Cohort C (1.0 g tablets)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Intelligem Therapeutics Australia Pty Ltd.: lead

Study Sites (6)

Emeritus Research Pty Ltd -Sydney

Botany, New South Wales, 2019, Australia

RECRUITING

Pendlebury Research Pty Ltd T/A Novatrials

Kotara, New South Wales, 2289, Australia

RECRUITING

Emeritus Research Pty Ltd -Melbourne

Camberwell, Victoria, 3124, Australia

RECRUITING

Chung Shan Medical University Hospital

Taichung, Taiwan, 402306, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan, 110301, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 333423, Taiwan

RECRUITING

MeSH Terms

Conditions

Hyperuricemia; Renal hypouricemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Central Study Contacts

Operation Team

CONTACT

+8610 53688632; clinicaltrials@intelligemtx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1 is a randomized, double-blind, placebo-controlled study. For each dose cohort in Part 1, the Sponsor, subjects and other personnel involved with the conduct of the study will be blinded to the study products. Part 2 is an open-label proof of concept study.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 15, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

AU (3); TW (3)