Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: Etanercept (Enbrel); Biological: HD203

• Registration Number: NCT01431404
• Lead Sponsor: Hanwha Chemical

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-05
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-09
• Primary Completion: 2012-03
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-03
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Enbrel, prefilled syringe	Etanercept (Enbrel)	-
HD203, prefilled syringe	HD203	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity	up to 49days

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of