Phase 1 Study(Additional) of URC102 in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02524678

Enrollment

Registered

2015-08-17

Start date

2015-08-05

Completion date

2016-03-28

Last updated

2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

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.

Interventions

DRUGPlacebo

DRUGURC102

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 49 Years

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

Design outcomes

Primary

Measure	Time frame
Number of participants with AE	2 week

Secondary

Measure	Time frame
Plasma URC102 concentration	2 week
Change of plasma uric acid	2 week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026