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OpenTrials
Completed

NCT Number: NCT00846274

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

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

Completed

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Key information

Conditions

Healthy

Age range

19 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SK chemicals

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SK Antithrombin III

Biological

Primary outcomes

  1. ATIII activity

    Time frame: within 20min after injection ATIII

Secondary outcomes

  1. ATIII antigen

    Time frame: within 20min after injection ATIII

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Collaborators

  • Korea University Anam Hospital

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 18, 2009
Registry last updated
Feb 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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