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

Single-Dose, Open Label, Randomized Comparative Clinical Trial to Evaluate the Tolerability, Safety and PK/PD of Human ATIII Products, SKATIII Injection andATIII Injection in Healthy Male Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00846274
Enrollment
20
Registered
2009-02-18
Start date
2008-10-31
Completion date
2008-12-31
Last updated
2009-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Male subjects

Brief summary

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

Interventions

BIOLOGICALSK Antithrombin III

Sponsors

Korea University Anam Hospital
CollaboratorOTHER
SK Chemicals Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
ATIII activitywithin 20min after injection ATIII

Secondary

MeasureTime frame
ATIII antigenwithin 20min after injection ATIII

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026