The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single dose of N-Rephasin® SAL200 in healthy male subjects.
The purposes of this study are to evaluate the pharmacokinetics, and pharmacodynamics and safety of an experimental intravenous medication, N-Rephasin® SAL200 in healthy male. Participants will include 36 male volunteers. Participants will be grouped according to dosage of N-Rephasin® SAL200 including placebo (0 mg/kg). Study procedures include: check of vital signs, reporting any experienced side effects, physical examination including assessment of the cardiovascular system, and blood sample collection for monitoring of pharmacokinetics, pharmacodynamics and antibody production etc. Participants will be involved in study related procedures for up to 50 days after injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
continuous intravenous infusion over 60 minutes
Formulation buffer for continuous intravenous infusion over 60 minutes
Seoul National University Hospital
Seoul, South Korea
Evaluation of the Safety of N-Rephasin® SAL200 in Healthy Human Volunteers
Time frame: Up to 50 days after administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.