Safety and Pharmacokinetic Characteristics of HD203 in Healthy Male Volunteers (SPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01044836
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : July 15, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: HD203 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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
Study Start Date : January 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Etanercept Biological: HD203
Injectable form

Primary Outcome Measures :
  1. Etanercept levels in blood [ Time Frame: 21 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 20 to 40 years of healthy volunteers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01044836

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanwha Chemical
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. Seoul National University Hospital

Responsible Party: Hanwha Chemical Identifier: NCT01044836     History of Changes
Other Study ID Numbers: EAGLE-I-09
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014

Keywords provided by Hanwha Chemical:
Healthy volunteer