Status:

COMPLETED

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

Lead Sponsor:

SK Chemicals Co., Ltd.

Collaborating Sponsors:

Korea University Anam Hospital

Conditions:

Healthy

Eligibility:

MALE

19-40 years

Phase:

PHASE1

Brief Summary

To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1 study in healthy male subjects was designed

Eligibility Criteria

Inclusion

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

Exclusion

  • Hb\<14g/dL, Hct\<42%
  • ATIII hypersensitivity

Key Trial Info

Start Date :

October 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2008

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00846274

Start Date

October 1 2008

End Date

December 1 2008

Last Update

February 18 2009

Active Locations (1)

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1

SK chemicals

Seoul, South Korea