protocolSection identificationModule nctId: NCT06310967, orgStudyIdInfo id: IG3018-23-02-01, briefTitle: A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Intelligem Therapeutics Australia Pty Ltd., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Hyperuricemia, conditions: Hypouricemia, Renal, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: 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 proof of concept study involving hyperuricemia subjects with advanced predialysis CKD (Stage 3A, Stage 3B and Stage 4), and treated with two doses \[0.5 g BID IG3018 (Cohort D) and 1.0 g BID IG3018 (Cohort E)\] . At least 5 to 8 hyperuricemia subjects with advanced CKD will be enrolled in each dose and will receive the determined study dose of IG3018 twice daily (BID) for 4 weeks., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: 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., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: IG3018, interventions name: Placebo matching IG3018, outcomesModule primaryOutcomes measure: Safety Assessments (Part 1 and Part 2), primaryOutcomes measure: The proportions of change from baseline in serum uric acid to normal level (≤ 0.36 mmol/L) (Part 1 and Part 2), secondaryOutcomes measure: 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), secondaryOutcomes measure: The actual change of serum uric acid (Part 1 and Part 2), secondaryOutcomes measure: The percentage change of serum uric acid (Part 1 and Part 2), secondaryOutcomes measure: Gouty Attacks (Part 1 and Part 2), secondaryOutcomes measure: Urinary Albumin/Creatinine Ration (U-ACR) (Part 2 only), secondaryOutcomes measure: Ae of IG3018 (Part 1 only), secondaryOutcomes measure: Cmax of IG3018 (Part 1 only), secondaryOutcomes measure: Tmax of IG3018 (Part 1 only), secondaryOutcomes measure: T1/2 of IG3018 (Part 1 only), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False