Phase 1 Study(Additional) of URC102 in Healthy Subjects

JW Pharmaceutical21 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

PlaceboDRUG

URC102DRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male volunteers Exclusion Criteria: * Participated in other clinical study within past 3 months prior to receiving an IP administration

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Number of participants with AE

Time frame: 2 week

Secondary Outcomes

Plasma URC102 concentration

Time frame: 2 week

Change of plasma uric acid

Time frame: 2 week

Data from ClinicalTrials.gov

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