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

SK Chemicals Co., Ltd.20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

SK Antithrombin IIIBIOLOGICAL

Eligibility

Sex: MALEMin age: 19 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * ages 19 to 40 * Body weight: More than 50kg * Healthy male subject Exclusion Criteria: * Hb\<14g/dL, Hct\<42% * ATIII hypersensitivity

Locations (1)

SK chemicals

Seoul, South Korea

Outcomes

Primary Outcomes

ATIII activity

Time frame: within 20min after injection ATIII

Secondary Outcomes

ATIII antigen

Time frame: within 20min after injection ATIII

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.