Phase 1 Study(Additional) of URC102 in Healthy Subjects

Phase 1

Completed

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

• Registration Number: NCT02524678
• Lead Sponsor: JW Pharmaceutical

Brief Summary

The purpose of this study is to assess the safety, tolerability, PK and PD of URC102 in healthy subjects.

Detailed Description

Tolerability, safety, and pharmacokinetics (PK) of URC102 will be assessed after 7-day repeated oral dose in healthy adult Korean males. In addition, pharmacodynamic (PD) response of blood and urinary uric acid levels will be assessed.

Study Timeline

• Study First Submitted: 2015-07-22
• Study Start: 2015-08-05
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-17
• Primary Completion: 2015-10-07
• Study Completion: 2016-03-28
• Status Verified: 2018-03
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

• Healthy male volunteers

Exclusion Criteria

• Participated in other clinical study within past 3 months prior to receiving an IP administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
URC102	URC102	URC102

Primary Outcome Measures

Name	Time	Method
Number of participants with AE	2 week

Secondary Outcome Measures

Name	Time	Method
Plasma URC102 concentration	2 week
Change of plasma uric acid	2 week

Trial Locations

Locations (1)

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