Safety and Pharmacokinetic Characteristics of HD203 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: HD203

• Registration Number: NCT01044836
• Lead Sponsor: Hanwha Chemical

Brief Summary

The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 with those of etanercept after subcutaneous injection in healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-13
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

• 20 to 40 years of healthy volunteers

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Etanercept	HD203	-

Primary Outcome Measures

Name	Time	Method
Etanercept levels in blood	21 days

Trial Locations

Locations (1)

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