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

This study has been completed.
Sponsor:
Collaborator:
Korea University Anam Hospital
Information provided by:
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00846274
First received: February 16, 2009
Last updated: February 17, 2009
Last verified: February 2009
  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
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

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders 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
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: 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

No publications provided by SK Chemicals Co.,Ltd.

Additional 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
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:
Antithrombins
Antithrombin III
Antithrombin Proteins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014