Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers

Hanwha Chemical48 enrolled

Overview

The purpose of this study is to compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Etanercept (Enbrel)BIOLOGICAL

HD203BIOLOGICAL

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 20 to 40 years of healthy volunteers Exclusion Criteria: * Subject who had been treated with Etanercept before

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

Time frame: up to 56 days

Data from ClinicalTrials.gov

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