Hyperuricemia Clinical Trial
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.
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)]. ;
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