SB17170 Phase1 Trial in Healthy Volunteer

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect, and Ethnicity Effect of SB17170 in Healthy Adult Subjects

Conditions
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Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics

Intervention / Treatment
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* Drug: SB17170
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Korean or Caucasian adults between the ages of 19 and 50 as of the date of written consent Subjects with a body weight of 55.0 kg or more at the time of screening and a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2 Written informed consent Exclusion Criteria: Clinical significant medical history Gastrointestinal disease or past history Hypersensitivity or clinically significant hypersensitivity to the components of investigational drugs Screening test AST, ALT > ULN x 1.5 Creatinine clearance < 60mL/min/1.73m2 QTcB interval > 450 ms Serologic test positive(Hepatitis B, Hepatitis C, HIV) SBP <90 mmHg or >150 mmHg, DBP <60 mmHg or > 100 mmHg Drub abuse history Administration of any OTC drug, Herbal drug, Investigational medication within 2weeks Participation in other clinical trial within 6 months

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB17170 of 50mg, Single dose<br>Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 50mg capsule, QD for 1 day(single). | Drug: SB17170<br>* Taking SB17170 orally once a day<br>* Other names: SB1703;|
| Placebo Comparator: Placebo of 50mg, Single dose<br>Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 50mg, QD for 1 day(single). | Drug: Placebo<br>* Taking Placebo orally once a day<br>|
| Experimental: SB17170 of 150mg, Single dose<br>Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 100mg and 50mg capsules, QD for 1 day(single). | Drug: SB17170<br>* Taking SB17170 orally once a day<br>* Other names: SB1703;|
| Placebo Comparator: Placebo of 150mg, Single dose<br>Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 100mg and 50mg capsules, QD for 1 day(single). | Drug: Placebo<br>* Taking Placebo orally once a day<br>|
| Experimental: SB17170 of 250mg, Single dose<br>Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg capsule, QD for 1 day(single). | Drug: SB17170<br>* Taking SB17170 orally once a day<br>* Other names: SB1703;|
| Placebo Comparator: Placebo of 250mg, Single dose<br>Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg capsule, QD for 1 day(single). | Drug: Placebo<br>* Taking Placebo orally once a day<br>|
| Experimental: SB17170 of 500mg, Single dose, Food-effect<br>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 1st period without a meal Wash out period more than 7 days 2nd period with a high-fat meal | Drug: SB17170<br>* Taking SB17170 orally once a day<br>* Other names: SB1703;|
| Placebo Comparator: Placebo of 500mg, Single dose, Food-effect<br>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 1st period without a meal Wash out period more than 7 days 2nd period with a high-fat meal | Drug: Placebo<br>* Taking Placebo orally once a day<br>|
| Experimental: SB17170 of 1000mg, Single dose<br>Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 4capsules, QD for 1 day(single). | Drug: SB17170<br>* Taking SB17170 orally once a day<br>* Other names: SB1703;|
| Placebo Comparator: Placebo of 1000mg, Single dose<br>Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 4 capsules, QD for 1 day(single). | Drug: Placebo<br>* Taking Placebo orally once a day<br>|
| Experimental: SB17170 of 1500mg, Single dose<br>Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 6 capsules, QD for 1 day(single). | Drug: SB17170<br>* Taking SB17170 orally once a day<br>* Other names: SB1703;|
| Placebo Comparator: Placebo of 1500mg, Single dose<br>Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg 6 capsules, QD for 1 day(single). | Drug: Placebo<br>* Taking Placebo orally once a day<br>|
| Experimental: SB17170 of 250mg, Multiple dose for 7days<br>Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 1 capsule, QD for 7 days(multiple). | Drug: SB17170<br>* Taking SB17170 orally once a day<br>* Other names: SB1703;|
| Placebo Comparator: Placebo of 250mg, Multiple dose for 7days<br>Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 1 capsule, QD for 7 days(multiple). | Drug: Placebo<br>* Taking Placebo orally once a day<br>|
| Experimental: SB17170 of 500mg, Multiple dose for 7days<br>Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 2 capsules, QD for 7 days(multiple). | Drug: SB17170<br>* Taking SB17170 orally once a day<br>* Other names: SB1703;|
| Placebo Comparator: Placebo of 500mg, Multiple dose for 7days<br>Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 2 capsules, QD for 7 days(multiple). | Drug: Placebo<br>* Taking Placebo orally once a day<br>|
| Experimental: SB17170 of 1000mg, Multiple dose for 7days<br>Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 4 capsules, QD for 7 days(multiple). | Drug: SB17170<br>* Taking SB17170 orally once a day<br>* Other names: SB1703;|
| Placebo Comparator: Placebo of 1000mg, Multiple dose for 7days<br>Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 4 capsules, QD for 7 days(multiple). | Drug: Placebo<br>* Taking Placebo orally once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HMGB1