Safety and Pharmacokinetic Characteristics of HD203 in Healthy Male Volunteers

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.

Completed

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

20 to 40 years of healthy volunteers

Treatment and study plan

HD203

Biological

Injectable form

Primary outcomes

Etanercept levels in blood

Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Hanwha Chemical

Industry

Registry information

Official study title

A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers

Acronym: SPH

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jan 8, 2010
Registry last updated: Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed