SB17170 Phase1 Trial in Healthy Volunteer

Sponsor

SPARK Biopharma (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05795192

Collaborator

(none)

Enrollment

Arms

10.5

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Safety Issues Tolerability Pharmacokinetics Pharmacodynamics	Drug: SB17170 Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Block randomized, double-blind design controlling with IWRS

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 14, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Mar 30, 2024

Arms and Interventions

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
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
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
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
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
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
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
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
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

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [From Day 1 to Day 7 for Single dose, From Day 1 to Day 9 for Multiple dose]
Safety and Tolerability in healthy subjects

Secondary Outcome Measures

The Area Under the Curve from dosing to the time of the last measured concentration [Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour]
Pharmacokinetic parameter
The area under the curve from time 0 extrapolated to infinite time(AUCinf) [Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour]
Pharmacokinetic parameter
The maximum (or peak) serum concentration(Cmax) [Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour]
Pharmacokinetic parameter
The time to reach Cmax(Tmax) [Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour]
Pharmacokinetic parameter
The Half life(t1/2) of SB17170 and active metabolite [Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour]
Pharmacokinetic parameter
The ratio of oral clearance(CL/F) [Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour]
Pharmacokinetic parameter
The Renal clearance(CLR) [Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour]
Pharmacokinetic parameter
The volume of distribution(vd/f) [Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour]
Pharmacokinetic parameter
The ratio of unchanged drug to metabolite(Metabolic ratio) [Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour]
Pharmacokinetic parameter
Compare the concentrations of HMGB1 between the active and placebo groups [Baseline 0 hour, 1.5hour, 24hour,]
High Mobility Group Box1(HMGB1) as a Pharmacodynamic parameter
Compare the concentrations of Interferon-gamma between the active and placebo groups [Baseline 0 hour, 1.5hour, 24hour,]
Interferon-gamma( IFN-γ) as a Pharmacodynamic parameter
Compare the concentrations of TNF-α between the active and placebo groups [Baseline 0 hour, 1.5hour, 24hour,]
Tumor Necrosis Factor-alpha human(TNF-α) as a Pharmacodynamic parameter
Compare the concentratiosn of Interleukin-6 between the active and placebo groups [Baseline 0 hour, 1.5hour, 24hour,]
Interleukin-6 as a Pharmacodynamic parameter

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

SPARK Biopharma

Investigators

Principal Investigator: SeungHwan Lee, M.D., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SPARK Biopharma

ClinicalTrials.gov Identifier:

NCT05795192

Other Study ID Numbers:

SMARTT-002

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by SPARK Biopharma

HMGB1

Study Results

No Results Posted as of Apr 5, 2023