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Completed

NCT Number: NCT02524678

Phase 1 Study(Additional) of URC102 in Healthy Subjects

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

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Key information

Conditions

Healthy

Age range

20 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteers

Exclusion criteria

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

Treatment and study plan

Placebo

Drug

URC102

Drug

Primary outcomes

  1. Number of participants with AE

    Time frame: 2 week

Secondary outcomes

  1. Plasma URC102 concentration

    Time frame: 2 week

  2. Change of plasma uric acid

    Time frame: 2 week

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Aug 17, 2015
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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