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Phase1 Syudy to Evaluate the Safety and PK/PD of Human Antithrombin III

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846274
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
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.
Collaborator:
Korea University Anam Hospital
Information provided by:
SK Chemicals Co.,Ltd.
  Purpose
To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1 study in healthy male subjects was designed

Condition Intervention Phase
Healthy Biological: SK Antithrombin III Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-Dose, Open Label, Randomized Comparative Clinical Trial to Evaluate the Tolerability, Safety and PK/PD of Human ATIII Products, "SKATIII Injection" and"ATIII Injection" in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:
  • ATIII activity [ Time Frame: within 20min after injection ATIII ]

Secondary Outcome Measures:
  • ATIII antigen [ Time Frame: within 20min after injection ATIII ]

Estimated Enrollment: 20
Study Start Date: October 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antithrombin III Biological: SK Antithrombin III
Experimental: SK Antithrombin III Biological: SK Antithrombin III

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages 19 to 40
  • Body weight: More than 50kg
  • Healthy male subject

Exclusion Criteria:

  • Hb<14g/dL, Hct<42%
  • ATIII hypersensitivity
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00846274


Locations
Korea, Republic of
SK chemicals
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Korea University Anam Hospital
Investigators
Principal Investigator: Ji Young Park, MD,PhD Korea University Anam Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Research Team, SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00846274     History of Changes
Other Study ID Numbers: SKATIII_I_2007
First Submitted: February 16, 2009
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
Last Verified: February 2009

Keywords provided by SK Chemicals Co.,Ltd.:
Healthy Male subjects

Additional relevant MeSH terms:
Antithrombins
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants