Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers

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

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

Exclusion criteria

Subject who had been treated with Etanercept before

Treatment and study plan

Etanercept (Enbrel)

Biological

HD203

Biological

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

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jul 10, 2013
Registry last updated: Jul 14, 2016

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