Phase 1 Study(Additional) of URC102 in Healthy Subjects

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: URC102

Study type: Interventional

Funder types: Industry

Identifiers

NCT02524678

URC004KR

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: Male

Ages: 20 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

URC102

Active Comparator group

Description:

URC102

Treatment:

Drug: URC102