The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single dosing study with three ascending dose cohorts of ISU302 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
24
Safety and tolerability
Evaluation for safety data by treatment group/ Confirmative evaluation for serious adverse drug reaction/ Descriptive statistics (arithmetic mean and standard deviation) for quantitative analysis and evaluation of change from baseline/ Frequency counts for qualitative categorization of safety data Parameters: * Adverse events including subjective/objective symptoms * Physical examination * 12-lead ECG * Vital signs * Local tolerability test * Clinical laboratory test: Hematology, Coagulation, Blood Chemistry, Urinalysis * Immunogenicity
Time frame: From Screening to Day 5 post-dose
Pharmacokinetics
Pharmacokinetic Parameter assessment using non-compartmental analysis from the concentration-time data/ Summary of Pharmacokinetic parameters by treatment group using descriptive statistics/ Dose proportionality Parameters: Cmax, AUCt, AUCinf, Tmax, t1/2, Clearance, Vd, MRTr
Time frame: Day1
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