SB17170 Phase1 Trial in Healthy Volunteer

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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Pharmacodynamics; Safety Issues; Tolerability
• Intervention / Treatment: Drug: SB17170; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

18

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SB17170 of 50mg, Single dose; Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 50mg capsule, QD for 1 day(single).	Drug: SB17170; Taking SB17170 orally once a day; Other Names: SB1703
Placebo Comparator: Placebo of 50mg, Single dose; Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 50mg, QD for 1 day(single).	Drug: Placebo; Taking Placebo orally once a day; Other Names: Control arm
Experimental: 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).	Drug: SB17170; Taking SB17170 orally once a day; Other Names: SB1703
Placebo Comparator: 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).	Drug: Placebo; Taking Placebo orally once a day; Other Names: Control arm
Experimental: SB17170 of 250mg, Single dose; Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg capsule, QD for 1 day(single).	Drug: SB17170; Taking SB17170 orally once a day; Other Names: SB1703
Placebo Comparator: Placebo of 250mg, Single dose; Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg capsule, QD for 1 day(single).	Drug: Placebo; Taking Placebo orally once a day; Other Names: Control arm
Experimental: 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	Drug: SB17170; Taking SB17170 orally once a day; Other Names: SB1703
Placebo Comparator: 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	Drug: Placebo; Taking Placebo orally once a day; Other Names: Control arm
Experimental: SB17170 of 1000mg, Single dose; Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 4capsules, QD for 1 day(single).	Drug: SB17170; Taking SB17170 orally once a day; Other Names: SB1703
Placebo Comparator: 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).	Drug: Placebo; Taking Placebo orally once a day; Other Names: Control arm
Experimental: 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).	Drug: SB17170; Taking SB17170 orally once a day; Other Names: SB1703
Placebo Comparator: 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).	Drug: Placebo; Taking Placebo orally once a day; Other Names: Control arm
Experimental: 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).	Drug: SB17170; Taking SB17170 orally once a day; Other Names: SB1703
Placebo Comparator: 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).	Drug: Placebo; Taking Placebo orally once a day; Other Names: Control arm
Experimental: 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).	Drug: SB17170; Taking SB17170 orally once a day; Other Names: SB1703
Placebo Comparator: 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).	Drug: Placebo; Taking Placebo orally once a day; Other Names: Control arm
Experimental: 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).	Drug: SB17170; Taking SB17170 orally once a day; Other Names: SB1703
Placebo Comparator: 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).	Drug: Placebo; Taking Placebo orally once a day; Other Names: Control arm

What is the study measuring?

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,

Collaborators and Investigators

• Sponsor: SPARK Biopharma
• Investigators: Principal Investigator: SeungHwan Lee, M.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: HMGB1
• Other Study ID Numbers: SMARTT-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No