NCT02524678

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2015

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

August 5, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2016

Completed
Last Updated

February 13, 2020

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

July 22, 2015

Last Update Submit

February 11, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with AE

    2 week

Secondary Outcomes (2)

  • Plasma URC102 concentration

    2 week

  • Change of plasma uric acid

    2 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

URC102

ACTIVE COMPARATOR

URC102

Drug: URC102

Interventions

PlaceboDRUG
Placebo
URC102DRUG
URC102

Eligibility Criteria

Age20 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Lee HA, Yu KS, Park SI, Yoon S, Onohara M, Ahn Y, Lee H. URC102, a potent and selective inhibitor of hURAT1, reduced serum uric acid in healthy volunteers. Rheumatology (Oxford). 2019 Nov 1;58(11):1976-1984. doi: 10.1093/rheumatology/kez140.

    PMID: 31056705DERIVED

MeSH Terms

Interventions

URC102

Study Officials

  • Howard Lee, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2015

First Posted

August 17, 2015

Study Start

August 5, 2015

Primary Completion

October 7, 2015

Study Completion

March 28, 2016

Last Updated

February 13, 2020

Record last verified: 2018-03

Locations

KR(1)