Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2023-05-24
2024-03-15
Brief Summary
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The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SB17170 of 50mg, Single dose
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 50mg capsule, QD for 1 day(single).
SB17170
Taking SB17170 orally once a day
Placebo of 50mg, Single dose
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 50mg, QD for 1 day(single).
Placebo
Taking Placebo orally once a day
SB17170 of 150mg, Single dose
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 100mg and 50mg capsules, QD for 1 day(single).
SB17170
Taking SB17170 orally once a day
Placebo of 150mg, Single dose
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 100mg and 50mg capsules, QD for 1 day(single).
Placebo
Taking Placebo orally once a day
SB17170 of 250mg, Single dose
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg capsule, QD for 1 day(single).
SB17170
Taking SB17170 orally once a day
Placebo of 250mg, Single dose
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg capsule, QD for 1 day(single).
Placebo
Taking Placebo orally once a day
SB17170 of 500mg, Single dose, Food-effect
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
SB17170
Taking SB17170 orally once a day
Placebo of 500mg, Single dose, Food-effect
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
Placebo
Taking Placebo orally once a day
SB17170 of 1000mg, Single dose
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 4capsules, QD for 1 day(single).
SB17170
Taking SB17170 orally once a day
Placebo of 1000mg, Single dose
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 4 capsules, QD for 1 day(single).
Placebo
Taking Placebo orally once a day
SB17170 of 1500mg, Single dose
Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 6 capsules, QD for 1 day(single).
SB17170
Taking SB17170 orally once a day
Placebo of 1500mg, Single dose
Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg 6 capsules, QD for 1 day(single).
Placebo
Taking Placebo orally once a day
SB17170 of 250mg, Multiple dose for 7days
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 1 capsule, QD for 7 days(multiple).
SB17170
Taking SB17170 orally once a day
Placebo of 250mg, Multiple dose for 7days
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 1 capsule, QD for 7 days(multiple).
Placebo
Taking Placebo orally once a day
SB17170 of 500mg, Multiple dose for 7days
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 2 capsules, QD for 7 days(multiple).
SB17170
Taking SB17170 orally once a day
Placebo of 500mg, Multiple dose for 7days
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 2 capsules, QD for 7 days(multiple).
Placebo
Taking Placebo orally once a day
SB17170 of 1000mg, Multiple dose for 7days
Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 4 capsules, QD for 7 days(multiple).
SB17170
Taking SB17170 orally once a day
Placebo of 1000mg, Multiple dose for 7days
Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 4 capsules, QD for 7 days(multiple).
Placebo
Taking Placebo orally once a day
Interventions
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SB17170
Taking SB17170 orally once a day
Placebo
Taking Placebo orally once a day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
50 Years
ALL
Yes
Sponsors
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SPARK Biopharma
INDUSTRY
Responsible Party
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Principal Investigators
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SeungHwan Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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SMARTT-002
Identifier Type: -
Identifier Source: org_study_id
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