Phase 1 Study of URC102 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: URC102

• Registration Number: NCT01953497
• Lead Sponsor: JW Pharmaceutical

Brief Summary

To assess the safety, tolerability, PK and PD of URC102 in healthy subjects. To evaluate the food effect on PK.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-23
• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-10-01
• Primary Completion: 2013-12-24
• Study Completion: 2014-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 81

Inclusion Criteria

• Healthy male volunteers

Exclusion Criteria

• Received other investigational drug within 12 weeks prior to the first dose of study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
URC102	URC102	URC102

Primary Outcome Measures

Name	Time	Method
Number of participants with AE	1 week

Secondary Outcome Measures

Name	Time	Method
Plasma URC102 concentration	1 week
Blood uric acid	1 week

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of