This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults. The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.
This clinical trial aims to learn about the safety, tolerability, and Pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults. The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults. The second questions are * To explore biomarkers and evaluate pharmacodynamic properties with ex-vivo test and proteome assay for SB17170 * To evaluate the effects of ethnic differences on the safety, tolerability, and pharmacokinetic properties of SB17170 in healthy Korean and Caucasian adults. * To evaluate the effect of food between Fast and high-fat meals on safety, tolerability, and pharmacokinetic properties of SB17170 in healthy adults. The difference between SB17170 and placebo on safety, tolerability, and PK/PD properties will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Seoul National University Hospital
Seoul, South Korea
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and Tolerability in healthy subjects
Time frame: From Day 1 to Day 7 for Single dose, From Day 1 to Day 9 for Multiple dose
The Area Under the Curve from dosing to the time of the last measured concentration
Pharmacokinetic parameter
Time frame: Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The area under the curve from time 0 extrapolated to infinite time(AUCinf)
Pharmacokinetic parameter
Time frame: Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The maximum (or peak) serum concentration(Cmax)
Pharmacokinetic parameter
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The time to reach Cmax(Tmax)
Pharmacokinetic parameter
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The Half life(t1/2) of SB17170 and active metabolite
Pharmacokinetic parameter
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The ratio of oral clearance(CL/F)
Pharmacokinetic parameter
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
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The Renal clearance(CLR)
Pharmacokinetic parameter
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The volume of distribution(vd/f)
Pharmacokinetic parameter
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The ratio of unchanged drug to metabolite(Metabolic ratio)
Pharmacokinetic parameter
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Compare the concentrations of TNF-α between the active and placebo groups
Tumor Necrosis Factor-alpha human(TNF-α) as a Pharmacodynamic parameter
Time frame: Baseline 0 hour, 1.5hour, 24hour,
Compare the concentratiosn of Interleukin-6 between the active and placebo groups
Interleukin-6 as a Pharmacodynamic parameter
Time frame: Baseline 0 hour, 1.5hour, 24hour,