Phase1 Syudy to Evaluate the Safety and PK/PD of Human An... | NCT00846274

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

NCT00846274

Sponsor

SK Chemicals Co., Ltd.

Status

Completed

Last Update Posted

Feb 18, 2009Estimated

Enrollment

20Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

SK Antithrombin III

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Feb 16, 2009

First Submission Date that Met QC Criteria

Feb 17, 2009

First Posted Date

Feb 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2009

Last Update Posted Date

Feb 18, 2009Estimated

Name	Class
Korea University Anam Hospital	OTHER

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antithrombin III	Active Comparator		Biological: SK Antithrombin III
SK Antithrombin III	Experimental		Biological: SK Antithrombin III

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SK Antithrombin III	Biological		Antithrombin III SK Antithrombin III

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ATIII activity		within 20min after injection ATIII

Secondary Outcomes

Measure	Description	Time Frame
ATIII antigen		within 20min after injection ATIII

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ji Young Park, MD,PhD	Korea University Anam Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SK chemicals		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24094463	Derived	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.