Phase 1 Study(Additional) of URC102 in Healthy Subjects

• Sponsor: JW Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02524678
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.8
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo; Drug: URC102	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase I, Placebo-controlled, Randomized, Double Blind, Dose-escalation Study to Assess the Safety and Pharmacokinetic and Pharmacodynamic Characteristics of Repeated-dose URC102 in Healthy Korean Adult Males
• Actual Study Start Date: Aug 5, 2015
• Actual Primary Completion Date: Oct 7, 2015
• Actual Study Completion Date: Mar 28, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo	Drug: Placebo
Active Comparator: URC102 URC102	Drug: URC102

Outcome Measures

Primary Outcome Measures

1. Number of participants with AE [2 week]

Secondary Outcome Measures

1. Plasma URC102 concentration [2 week]

2. Change of plasma uric acid [2 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 49 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male volunteers

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• JW Pharmaceutical

Investigators

• Principal Investigator: Howard Lee, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JW Pharmaceutical
• ClinicalTrials.gov Identifier: NCT02524678
• Other Study ID Numbers: URC004KR
• First Posted: Aug 17, 2015
• Last Update Posted: Feb 13, 2020
• Last Verified: Mar 1, 2018

Study Results

No Results Posted as of Feb 13, 2020