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

This study has been completed.
Korea University Anam Hospital
Information provided by:
SK Chemicals Co.,Ltd. Identifier:
First received: February 16, 2009
Last updated: February 17, 2009
Last verified: February 2009
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
Biological: SK Antithrombin III
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ATIII antigen [ Time Frame: within 20min after injection ATIII ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Hb<14g/dL, Hct<42%
  • ATIII hypersensitivity
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Please refer to this study by its identifier: NCT00846274

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

No publications provided by SK Chemicals Co.,Ltd.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Clinical Research Team, SK Chemicals Co.,Ltd. Identifier: NCT00846274     History of Changes
Other Study ID Numbers: SKATIII_I_2007
Study First Received: February 16, 2009
Last Updated: February 17, 2009
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Antithrombin III
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses processed this record on November 25, 2015