Phase 1 Study(Additional) of URC102 in Healthy Subjects

February 11, 2020 updated by: JW Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with AE
Time Frame: 2 week
2 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma URC102 concentration
Time Frame: 2 week
2 week
Change of plasma uric acid
Time Frame: 2 week
2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2015

Primary Completion (Actual)

October 7, 2015

Study Completion (Actual)

March 28, 2016

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 17, 2015

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • URC004KR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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