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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
The difference between SB17170 and placebo on safety, tolerability, and PK/PD properties will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB17170 of 50mg, Single dose | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 50mg capsule, QD for 1 day(single). |
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| Placebo of 50mg, Single dose | Placebo Comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 50mg, QD for 1 day(single). |
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| SB17170 of 150mg, Single dose | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 100mg and 50mg capsules, QD for 1 day(single). |
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| Placebo of 150mg, Single dose | Placebo Comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 100mg and 50mg capsules, QD for 1 day(single). |
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| SB17170 of 250mg, Single dose | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg capsule, QD for 1 day(single). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB17170 | Drug | Taking SB17170 orally once a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Safety and Tolerability in healthy subjects | From Day 1 to Day 7 for Single dose, From Day 1 to Day 9 for Multiple dose |
| Measure | Description | Time Frame |
|---|---|---|
| The Area Under the Curve from dosing to the time of the last measured concentration | Pharmacokinetic parameter | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SeungHwan Lee, M.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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Block randomized, double-blind design controlling with IWRS
| Placebo of 250mg, Single dose |
| Placebo Comparator |
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg capsule, QD for 1 day(single). |
|
| SB17170 of 500mg, Single dose, Food-effect | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 2 capsules, QD for 1 day(single). Food-effect test for the expected efficacy dose
|
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| Placebo of 500mg, Single dose, Food-effect | Placebo Comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 2 capsules, QD for 1 day(single). Food-effect test for the expected efficacy dose
|
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| SB17170 of 1000mg, Single dose | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 4capsules, QD for 1 day(single). |
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| Placebo of 1000mg, Single dose | Placebo Comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 4 capsules, QD for 1 day(single). |
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| SB17170 of 1500mg, Single dose | Experimental | Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 6 capsules, QD for 1 day(single). |
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| Placebo of 1500mg, Single dose | Placebo Comparator | Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg 6 capsules, QD for 1 day(single). |
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| SB17170 of 250mg, Multiple dose for 7days | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 1 capsule, QD for 7 days(multiple). |
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| Placebo of 250mg, Multiple dose for 7days | Placebo Comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 1 capsule, QD for 7 days(multiple). |
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| SB17170 of 500mg, Multiple dose for 7days | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 2 capsules, QD for 7 days(multiple). |
|
| Placebo of 500mg, Multiple dose for 7days | Placebo Comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 2 capsules, QD for 7 days(multiple). |
|
| SB17170 of 1000mg, Multiple dose for 7days | Experimental | Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 4 capsules, QD for 7 days(multiple). |
|
| Placebo of 1000mg, Multiple dose for 7days | Placebo Comparator | Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 4 capsules, QD for 7 days(multiple). |
|
| Placebo | Drug | Taking Placebo orally once a day |
|
Pharmacokinetic parameter |
| Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour |
| The maximum (or peak) serum concentration(Cmax) | Pharmacokinetic parameter | Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour |
| The time to reach Cmax(Tmax) | Pharmacokinetic parameter | 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 | Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour |
| The ratio of oral clearance(CL/F) | Pharmacokinetic parameter | Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour |
| The Renal clearance(CLR) | Pharmacokinetic parameter | Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour |
| The volume of distribution(vd/f) | Pharmacokinetic parameter | 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 | 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 | Baseline 0 hour, 1.5hour, 24hour, |
| Compare the concentratiosn of Interleukin-6 between the active and placebo groups | Interleukin-6 as a Pharmacodynamic parameter | Baseline 0 hour, 1.5hour, 24hour, |