Clinical trial NCT05795192: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety Issues
Tolerability
Pharmacokinetics
Pharmacodynamics
Keywords: HMGB1
Lead sponsor: SPARK Biopharma
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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
Secondary outcomes:
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
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
measure: The maximum (or peak) serum concentration(Cmax)
timeFrame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
measure: The time to reach Cmax(Tmax)
timeFrame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
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
measure: The ratio of oral clearance(CL/F)
timeFrame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
measure: The Renal clearance(CLR)
timeFrame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
measure: The volume of distribution(vd/f)
timeFrame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
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
measure: Compare the concentrations of TNF-α between the active and placebo groups
timeFrame: Baseline 0 hour, 1.5hour, 24hour,
measure: Compare the concentratiosn of Interleukin-6 between the active and placebo groups
timeFrame: Baseline 0 hour, 1.5hour, 24hour,
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: SeungHwan Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: