Gout Clinical Trial
Official title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of XNW3009 in Healthy Adult Subject
XNW3009 is a small molecule hURAT1 inhibitor developed independently by Sinovent Pty Ltd., and is intended to treat gout-related hyperuricemia. Uricosuric drugs increase urinary uric acid excretion by blocking renal tubular reabsorption of urate. The human urate transporter 1( hURAT1) is responsible for the majority of the reabsorption of filtered urate, and the mutations in the hURAT1 gene have been demonstrated to be responsible for urate non-homeostasis. This is a randomized, double-blind, placebo-controlled, dose-escalation study to investigate the safety, tolerability, PK and PD of XNW3009 after administration of single (Part A) and multiple (Part B) oral doses in healthy adult subjects. Approximately six sequential dose panels (single oral doses of 1, 5, 10, 20, 35 and 50 mg XNW3009) will be evaluated in SAD and approximately three sequential dose panels (ten consecutive days for respectively daily oral doses of 10, 20,35 mg, QD) will be evaluated in MAD.
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