This trial is active, not recruiting.

Condition healthy
Treatments urc102, placebo
Phase phase 1
Sponsor JW Pharmaceutical
Start date June 2013
End date December 2013
Trial size 80 participants
Trial identifier NCT01953497, URC001KR


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Placebo Comparator)
(Active Comparator)

Primary Outcomes

Number of participants with AE
time frame: 1 week

Secondary Outcomes

Plasma URC102 concentration
time frame: 1 week
Blood uric acid
time frame: 1 week

Eligibility Criteria

Male participants from 20 years up to 50 years old.

Inclusion Criteria

  • Healthy male volunteers

Exclusion Criteria

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

Additional Information

Official title 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
Principal investigator Kyung-Sang Yu, MD, PhD, MBA
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by JW Pharmaceutical.