Phase 1 Study of URC102 in Healthy Subjects

A Phase I, Placebo-controlled, Randomized, Double Blind, Single or Multiple Dose Study of URC102 in Healthy Male Volunteers of Korean and Caucasian to Assess Safety, Pharmacokinetics and Pharmacodynamics

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01953497

Enrollment

Registered

2013-10-01

Start date

2013-05-23

Completion date

2014-07-31

Last updated

2017-03-08

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

Conditions

Healthy

Brief summary

To assess the safety, tolerability, PK and PD of URC102 in healthy subjects. To evaluate the food effect on PK.

Interventions

DRUGURC102

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male volunteers

Exclusion criteria

* Received other investigational drug within 12 weeks prior to the first dose of study drug

Design outcomes

Primary

Measure	Time frame
Number of participants with AE	1 week

Secondary

Measure	Time frame
Plasma URC102 concentration	1 week
Blood uric acid	1 week

Countries

South Korea

Outcome results

None listed

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