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.
Male or female, aged 18 to 75 years (both inclusive).
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.
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.
Sequential
IG3018
DrugOral administration
Placebo matching IG3018
Other interventionOral administration
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).
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.
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.
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.
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.
Gouty Attacks (Part 1 and Part 2)
Incidence of reported gouty attacks during the study period.
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