Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanwha Chemical
ClinicalTrials.gov Identifier:
NCT01431404
First received: September 5, 2011
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: Etanercept (Enbrel)
Biological: HD203
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized,Double-blind,Single-dosing,Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 With Active Comparator

Resource links provided by NLM:


Further study details as provided by Hanwha Chemical:

Primary Outcome Measures:
  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity [ Time Frame: up to 49days ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enbrel, prefilled syringe Biological: Etanercept (Enbrel)
prefilled syringe, SC
Experimental: HD203, prefilled syringe Biological: HD203
HD203, prefilled syringe, SC 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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431404

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

No publications provided

Responsible Party: Hanwha Chemical
ClinicalTrials.gov Identifier: NCT01431404     History of Changes
Other Study ID Numbers: EAGLE-I-11
Study First Received: September 5, 2011
Last Updated: July 3, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014