NCT03015948

A Single Dose Study of SHR4640 in Healthy Male Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Atridia Pty Ltd. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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).

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	SHR4640	a single dose of SHR4640 (n=8) for each dose cohort
DRUG	Placebo	a single dose of placebo (n=2) for each dose cohort .

Timeline

• Start date: 2016-09-22
• Primary completion: 2016-11-23
• Completion: 2016-11-23
• First posted: 2017-01-10
• Last updated: 2018-07-03

Locations

1 site across 1 country: Australia