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SB17170 Phase1 Trial in Healthy Volunteer

Primary Purpose

Safety Issues, Tolerability, Pharmacokinetics

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SB17170
Placebo
Sponsored by
SPARK Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Safety Issues focused on measuring HMGB1

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

SB17170 of 50mg, Single dose

Placebo of 50mg, Single dose

SB17170 of 150mg, Single dose

Placebo of 150mg, Single dose

SB17170 of 250mg, Single dose

Placebo of 250mg, Single dose

SB17170 of 500mg, Single dose, Food-effect

Placebo of 500mg, Single dose, Food-effect

SB17170 of 1000mg, Single dose

Placebo of 1000mg, Single dose

SB17170 of 1500mg, Single dose

Placebo of 1500mg, Single dose

SB17170 of 250mg, Multiple dose for 7days

Placebo of 250mg, Multiple dose for 7days

SB17170 of 500mg, Multiple dose for 7days

Placebo of 500mg, Multiple dose for 7days

SB17170 of 1000mg, Multiple dose for 7days

Placebo of 1000mg, Multiple dose for 7days

Arm Description

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 50mg capsule, QD for 1 day(single).

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 50mg, QD for 1 day(single).

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 100mg and 50mg capsules, QD for 1 day(single).

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 100mg and 50mg capsules, QD for 1 day(single).

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg capsule, QD for 1 day(single).

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg capsule, QD for 1 day(single).

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

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

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 4capsules, QD for 1 day(single).

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 4 capsules, QD for 1 day(single).

Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 6 capsules, QD for 1 day(single).

Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg 6 capsules, QD for 1 day(single).

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 1 capsule, QD for 7 days(multiple).

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 1 capsule, QD for 7 days(multiple).

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 2 capsules, QD for 7 days(multiple).

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 2 capsules, QD for 7 days(multiple).

Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 4 capsules, QD for 7 days(multiple).

Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 4 capsules, QD for 7 days(multiple).

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and Tolerability in healthy subjects

Secondary Outcome Measures

The Area Under the Curve from dosing to the time of the last measured concentration
Pharmacokinetic parameter
The area under the curve from time 0 extrapolated to infinite time(AUCinf)
Pharmacokinetic parameter
The maximum (or peak) serum concentration(Cmax)
Pharmacokinetic parameter
The time to reach Cmax(Tmax)
Pharmacokinetic parameter
The Half life(t1/2) of SB17170 and active metabolite
Pharmacokinetic parameter
The ratio of oral clearance(CL/F)
Pharmacokinetic parameter
The Renal clearance(CLR)
Pharmacokinetic parameter
The volume of distribution(vd/f)
Pharmacokinetic parameter
The ratio of unchanged drug to metabolite(Metabolic ratio)
Pharmacokinetic parameter
Compare the concentrations of TNF-α between the active and placebo groups
Tumor Necrosis Factor-alpha human(TNF-α) as a Pharmacodynamic parameter
Compare the concentratiosn of Interleukin-6 between the active and placebo groups
Interleukin-6 as a Pharmacodynamic parameter

Full Information

First Posted
February 27, 2023
Last Updated
October 16, 2023
Sponsor
SPARK Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT05795192
Brief Title
SB17170 Phase1 Trial in Healthy Volunteer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SPARK Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
Keywords
HMGB1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Block randomized, double-blind design controlling with IWRS
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SB17170 of 50mg, Single dose
Arm Type
Experimental
Arm Description
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 50mg capsule, QD for 1 day(single).
Arm Title
Placebo of 50mg, Single dose
Arm Type
Placebo Comparator
Arm Description
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 50mg, QD for 1 day(single).
Arm Title
SB17170 of 150mg, Single dose
Arm Type
Experimental
Arm Description
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 100mg and 50mg capsules, QD for 1 day(single).
Arm Title
Placebo of 150mg, Single dose
Arm Type
Placebo Comparator
Arm Description
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 100mg and 50mg capsules, QD for 1 day(single).
Arm Title
SB17170 of 250mg, Single dose
Arm Type
Experimental
Arm Description
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg capsule, QD for 1 day(single).
Arm Title
Placebo of 250mg, Single dose
Arm Type
Placebo Comparator
Arm Description
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg capsule, QD for 1 day(single).
Arm Title
SB17170 of 500mg, Single dose, Food-effect
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo of 500mg, Single dose, Food-effect
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
SB17170 of 1000mg, Single dose
Arm Type
Experimental
Arm Description
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 4capsules, QD for 1 day(single).
Arm Title
Placebo of 1000mg, Single dose
Arm Type
Placebo Comparator
Arm Description
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 4 capsules, QD for 1 day(single).
Arm Title
SB17170 of 1500mg, Single dose
Arm Type
Experimental
Arm Description
Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 6 capsules, QD for 1 day(single).
Arm Title
Placebo of 1500mg, Single dose
Arm Type
Placebo Comparator
Arm Description
Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg 6 capsules, QD for 1 day(single).
Arm Title
SB17170 of 250mg, Multiple dose for 7days
Arm Type
Experimental
Arm Description
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 1 capsule, QD for 7 days(multiple).
Arm Title
Placebo of 250mg, Multiple dose for 7days
Arm Type
Placebo Comparator
Arm Description
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 1 capsule, QD for 7 days(multiple).
Arm Title
SB17170 of 500mg, Multiple dose for 7days
Arm Type
Experimental
Arm Description
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 2 capsules, QD for 7 days(multiple).
Arm Title
Placebo of 500mg, Multiple dose for 7days
Arm Type
Placebo Comparator
Arm Description
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 2 capsules, QD for 7 days(multiple).
Arm Title
SB17170 of 1000mg, Multiple dose for 7days
Arm Type
Experimental
Arm Description
Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 4 capsules, QD for 7 days(multiple).
Arm Title
Placebo of 1000mg, Multiple dose for 7days
Arm Type
Placebo Comparator
Arm Description
Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 4 capsules, QD for 7 days(multiple).
Intervention Type
Drug
Intervention Name(s)
SB17170
Other Intervention Name(s)
SB1703
Intervention Description
Taking SB17170 orally once a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Taking Placebo orally once a day
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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
Secondary Outcome Measure Information:
Title
The Area Under the Curve from dosing to the time of the last measured concentration
Description
Pharmacokinetic parameter
Time Frame
Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Title
The area under the curve from time 0 extrapolated to infinite time(AUCinf)
Description
Pharmacokinetic parameter
Time Frame
Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Title
The maximum (or peak) serum concentration(Cmax)
Description
Pharmacokinetic parameter
Time Frame
Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Title
The time to reach Cmax(Tmax)
Description
Pharmacokinetic parameter
Time Frame
Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Title
The Half life(t1/2) of SB17170 and active metabolite
Description
Pharmacokinetic parameter
Time Frame
Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Title
The ratio of oral clearance(CL/F)
Description
Pharmacokinetic parameter
Time Frame
Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Title
The Renal clearance(CLR)
Description
Pharmacokinetic parameter
Time Frame
Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Title
The volume of distribution(vd/f)
Description
Pharmacokinetic parameter
Time Frame
Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Title
The ratio of unchanged drug to metabolite(Metabolic ratio)
Description
Pharmacokinetic parameter
Time Frame
Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Title
Compare the concentrations of TNF-α between the active and placebo groups
Description
Tumor Necrosis Factor-alpha human(TNF-α) as a Pharmacodynamic parameter
Time Frame
Baseline 0 hour, 1.5hour, 24hour,
Title
Compare the concentratiosn of Interleukin-6 between the active and placebo groups
Description
Interleukin-6 as a Pharmacodynamic parameter
Time Frame
Baseline 0 hour, 1.5hour, 24hour,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soojin Jun
Phone
8228879971
Email
sjjun@sparkbio.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
YongMi Yu
Phone
8228879905
Email
ymyu@sparkbio.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SeungHwan Lee, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SeungHwan Lee, Ph.D.
Phone
82-2-2072-2343

12. IPD Sharing Statement

Plan to Share IPD
No

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SB17170 Phase1 Trial in Healthy Volunteer

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