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

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: SK Antithrombin III

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00846274

SKATIII_I_2007

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: Male

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Antithrombin III

Active Comparator group

Treatment:

Biological: SK Antithrombin III

SK Antithrombin III

Experimental group

Treatment:

Biological: SK Antithrombin III