NCT04040907

The the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XNW3009 in Health Subject

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Evopoint Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	XNW3009	XNW3009 is a small molecule hURAT1 inhibitor
DRUG	Placebo	Placebo and active drug will have the same appearance

Timeline

• Start date: 2019-11-13
• Primary completion: 2021-01-20
• Completion: 2021-05-30
• First posted: 2019-08-01
• Last updated: 2023-02-16

Locations

1 site across 1 country: Australia