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A Single Dose Study of SHR4640 in Healthy Male Volunteers

Gout Clinical Trial

Official title:
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose of SHR4640 in Healthy Male Volunteers

Clinical Trial Summary

This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose Phase I trial.

Clinical Trial Description

This study includes screening (Days -16 to -3), check-in (Day -2), enrollment (Day -1), dosing (Day 1), observational period (Days 2 to 3), discharge day (Day 4), and safety follow-up visit (Day 8). Forty eligible subjects will be enrolled into 4 dose cohorts (10 for each cohort), and every 10 subjects will be randomized in a 4:1 ratio to receive a single dose of either SHR4640 (n=8) or placebo (n=2). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03015948
Study type Interventional
Source Atridia Pty Ltd.
Contact
Status Completed
Phase Phase 1
Start date September 22, 2016
Completion date November 23, 2016
View Details
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