Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-28 @ 2:13 PM
Study NCT ID:
NCT05795192
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SB17170 Phase1 Trial in Healthy Volunteer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Block randomized, double-blind design controlling with IWRS'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'From Day 1 to Day 7 for Single dose, From Day 1 to Day 9 for Multiple dose', 'description': 'Safety and Tolerability in healthy subjects'}], 'secondaryOutcomes': [{'measure': 'The Area Under the Curve from dosing to the time of the last measured concentration', 'timeFrame': 'Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour', 'description': 'Pharmacokinetic parameter'}, {'measure': 'The area under the curve from time 0 extrapolated to infinite time(AUCinf)', 'timeFrame': 'Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour', 'description': 'Pharmacokinetic parameter'}, {'measure': 'The maximum (or peak) serum concentration(Cmax)', 'timeFrame': 'Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour', 'description': 'Pharmacokinetic parameter'}, {'measure': 'The time to reach Cmax(Tmax)', 'timeFrame': 'Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour', 'description': 'Pharmacokinetic parameter'}, {'measure': 'The Half life(t1/2) of SB17170 and active metabolite', 'timeFrame': 'Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour', 'description': 'Pharmacokinetic parameter'}, {'measure': 'The ratio of oral clearance(CL/F)', 'timeFrame': 'Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour', 'description': 'Pharmacokinetic parameter'}, {'measure': 'The Renal clearance(CLR)', 'timeFrame': 'Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour', 'description': 'Pharmacokinetic parameter'}, {'measure': 'The volume of distribution(vd/f)', 'timeFrame': 'Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour', 'description': 'Pharmacokinetic parameter'}, {'measure': 'The ratio of unchanged drug to metabolite(Metabolic ratio)', 'timeFrame': 'Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour', 'description': 'Pharmacokinetic parameter'}, {'measure': 'Compare the concentrations of TNF-α between the active and placebo groups', 'timeFrame': 'Baseline 0 hour, 1.5hour, 24hour,', 'description': 'Tumor Necrosis Factor-alpha human(TNF-α) as a Pharmacodynamic parameter'}, {'measure': 'Compare the concentratiosn of Interleukin-6 between the active and placebo groups', 'timeFrame': 'Baseline 0 hour, 1.5hour, 24hour,', 'description': 'Interleukin-6 as a Pharmacodynamic parameter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HMGB1'], 'conditions': ['Safety Issues', 'Tolerability', 'Pharmacokinetics', 'Pharmacodynamics']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.', 'detailedDescription': '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.\n\nThe main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.\n\nThe second questions are\n\n* To explore biomarkers and evaluate pharmacodynamic properties with ex-vivo test and proteome assay for SB17170\n* To evaluate the effects of ethnic differences on the safety, tolerability, and pharmacokinetic properties of SB17170 in healthy Korean and Caucasian adults.\n* To evaluate the effect of food between Fast and high-fat meals on safety, tolerability, and pharmacokinetic properties of SB17170 in healthy adults.\n\nThe difference between SB17170 and placebo on safety, tolerability, and PK/PD properties will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Korean or Caucasian adults between the ages of 19 and 50 as of the date of written consent\n* 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\n* Written informed consent\n\nExclusion Criteria:\n\n* Clinical significant medical history\n* Gastrointestinal disease or past history\n* Hypersensitivity or clinically significant hypersensitivity to the components of investigational drugs\n* 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)\n* SBP \\<90 mmHg or \\>150 mmHg, DBP \\<60 mmHg or \\> 100 mmHg\n* Drub abuse history\n* Administration of any OTC drug, Herbal drug, Investigational medication within 2weeks\n* Participation in other clinical trial within 6 months'}, 'identificationModule': {'nctId': 'NCT05795192', 'briefTitle': 'SB17170 Phase1 Trial in Healthy Volunteer', 'organization': {'class': 'INDUSTRY', 'fullName': 'SPARK Biopharma'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SMARTT-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SB17170 of 50mg, Single dose', 'description': 'Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 50mg capsule, QD for 1 day(single).', 'interventionNames': ['Drug: SB17170']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of 50mg, Single dose', 'description': 'Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 50mg, QD for 1 day(single).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SB17170 of 150mg, Single dose', 'description': 'Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 100mg and 50mg capsules, QD for 1 day(single).', 'interventionNames': ['Drug: SB17170']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of 150mg, Single dose', 'description': 'Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 100mg and 50mg capsules, QD for 1 day(single).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SB17170 of 250mg, Single dose', 'description': 'Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg capsule, QD for 1 day(single).', 'interventionNames': ['Drug: SB17170']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of 250mg, Single dose', 'description': 'Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg capsule, QD for 1 day(single).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SB17170 of 500mg, Single dose, Food-effect', 'description': 'Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 2 capsules, QD for 1 day(single).\n\nFood-effect test for the expected efficacy dose\n\n* 1st period without a meal\n* Wash out period more than 7 days\n* 2nd period with a high-fat meal', 'interventionNames': ['Drug: SB17170']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of 500mg, Single dose, Food-effect', 'description': 'Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 2 capsules, QD for 1 day(single).\n\nFood-effect test for the expected efficacy dose\n\n* 1st period without a meal\n* Wash out period more than 7 days\n* 2nd period with a high-fat meal', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SB17170 of 1000mg, Single dose', 'description': 'Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 4capsules, QD for 1 day(single).', 'interventionNames': ['Drug: SB17170']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of 1000mg, Single dose', 'description': 'Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 4 capsules, QD for 1 day(single).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SB17170 of 1500mg, Single dose', 'description': 'Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 6 capsules, QD for 1 day(single).', 'interventionNames': ['Drug: SB17170']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of 1500mg, Single dose', 'description': 'Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg 6 capsules, QD for 1 day(single).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SB17170 of 250mg, Multiple dose for 7days', 'description': 'Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 1 capsule, QD for 7 days(multiple).', 'interventionNames': ['Drug: SB17170']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of 250mg, Multiple dose for 7days', 'description': 'Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 1 capsule, QD for 7 days(multiple).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SB17170 of 500mg, Multiple dose for 7days', 'description': 'Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 2 capsules, QD for 7 days(multiple).', 'interventionNames': ['Drug: SB17170']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of 500mg, Multiple dose for 7days', 'description': 'Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 2 capsules, QD for 7 days(multiple).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SB17170 of 1000mg, Multiple dose for 7days', 'description': 'Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 4 capsules, QD for 7 days(multiple).', 'interventionNames': ['Drug: SB17170']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of 1000mg, Multiple dose for 7days', 'description': 'Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 4 capsules, QD for 7 days(multiple).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SB17170', 'type': 'DRUG', 'description': 'Taking SB17170 orally once a day', 'armGroupLabels': ['SB17170 of 1000mg, Multiple dose for 7days', 'SB17170 of 1000mg, Single dose', 'SB17170 of 1500mg, Single dose', 'SB17170 of 150mg, Single dose', 'SB17170 of 250mg, Multiple dose for 7days', 'SB17170 of 250mg, Single dose', 'SB17170 of 500mg, Multiple dose for 7days', 'SB17170 of 500mg, Single dose, Food-effect', 'SB17170 of 50mg, Single dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Taking Placebo orally once a day', 'armGroupLabels': ['Placebo of 1000mg, Multiple dose for 7days', 'Placebo of 1000mg, Single dose', 'Placebo of 1500mg, Single dose', 'Placebo of 150mg, Single dose', 'Placebo of 250mg, Multiple dose for 7days', 'Placebo of 250mg, Single dose', 'Placebo of 500mg, Multiple dose for 7days', 'Placebo of 500mg, Single dose, Food-effect', 'Placebo of 50mg, Single dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'SeungHwan Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SPARK Biopharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}