NCT00846274CompletedPhase 1
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- SK Chemicals Co., Ltd.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- ATIII activity
Study Overview
Brief Summary
To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1 study in healthy male subjects was designed
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 40 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
Antithrombin III
Active Comparator
Intervention: SK Antithrombin III (Biological)
SK Antithrombin III
Experimental
Intervention: SK Antithrombin III (Biological)
Outcomes
Primary Outcomes
ATIII activity
Time Frame: within 20min after injection ATIII
Secondary Outcomes
- ATIII antigen(within 20min after injection ATIII)
Investigators
Study Sites (1)
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