NCT00846274

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

2 months

First QC Date

February 16, 2009

Last Update Submit

February 17, 2009

Conditions

Healthy

Keywords

Healthy Male subjects

Outcome Measures

Primary Outcomes (1)

  • ATIII activity

    within 20min after injection ATIII

Secondary Outcomes (1)

  • ATIII antigen

    within 20min after injection ATIII

Study Arms (2)

Antithrombin III

ACTIVE COMPARATOR
Biological: SK Antithrombin III

SK Antithrombin III

EXPERIMENTAL
Biological: SK Antithrombin III

Interventions

SK Antithrombin IIIBIOLOGICAL
Antithrombin IIISK Antithrombin III

Eligibility Criteria

Age19 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SK chemicals

Seoul, South Korea

Location

Related Publications (1)

  • Kim KA, Lim YY, Kim SH, Park JY. Bioequivalence of two intravenous formulations of antithrombin III: a two-way crossover study in healthy Korean subjects. Clin Ther. 2013 Nov;35(11):1752-61. doi: 10.1016/j.clinthera.2013.08.018. Epub 2013 Oct 1.

    PMID: 24094463DERIVED

Study Officials

  • Ji Young Park, MD,PhD

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 16, 2009

First Posted

February 18, 2009

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

KR(1)