| Outcome Measures: |
Primary: 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: 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., 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., 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., 4 weeks|Gouty Attacks (Part 1 and Part 2), Incidence of reported gouty attacks during the study period., 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., Baseline through study completion at up to 43 days|Ae of IG3018 (Part 1 only), Urine Accumulative excretion (Ae) of IG3018, 32 days|Cmax of IG3018 (Part 1 only), Maximum observed whole blood concentration of IG3018, 46 days|Tmax of IG3018 (Part 1 only), Time to reach maximum whole blood concentration of IG3018, 46 days|T1/2 of IG3018 (Part 1 only), Terminal half-life of IG3018, 46 days|Estimated glomerular filtration rate (eGFR) (Part 2 only), The change in estimated glomerular filtration rate (eGFR) during the study period., Baseline through study completion at up to 43 days|Cmax of IG3018 (Part 2 Taiwanese subjects only), Maximum observed whole blood concentration of IG3018, 43 days|Tmax of IG3018 (Part 2 Taiwanese subjects only), Time to reach maximum whole blood concentration of IG3018, 43 days|T1/2 of IG3018 (Part 2 Taiwanese subjects only), Terminal half-life of IG3018, 43 days
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| Locations: |
Emeritus Research Pty Ltd -Sydney, Botany, New South Wales, 2019, Australia|Pendlebury Research Pty Ltd T/A Novatrials, Kotara, New South Wales, 2289, Australia|Emeritus Research Pty Ltd -Melbourne, Camberwell, Victoria, 3124, Australia
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