Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects

Hanwha Chemical44 enrolled

Overview

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

A randomized, double-blind, single-dosing, crossover study to compare the safety and pharmacokinetic characteristics of HD203 Liquid 25 mg with those of Enbrel Prefilled® injection 25 mg after subcutaneous injection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Etanercept (Enbrel)BIOLOGICAL

prefilled syringe, SC

HD203BIOLOGICAL

HD203, prefilled syringe, SC injection

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * 20 to 40 years of healthy volunteers * Weight over 55kg * Subject who signed on ICF 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 49days

Data from ClinicalTrials.gov

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