Phase 1 Study of URC102 in Healthy Subjects

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: URC102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01953497

URC001KR

Details and patient eligibility

About

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

Enrollment: 81 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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81 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