Pharmacodynamics, Pharmacokinetics, Safety Issues, Tolerability
Conditions
Keywords
HMGB1
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.
Interventions
DRUGSB17170
Taking SB17170 orally once a day
DRUGPlacebo
Taking Placebo orally once a day
Sponsors
SPARK Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Block randomized, double-blind design controlling with IWRS
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 |
| The Renal clearance(CLR) | Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour | Pharmacokinetic parameter |
Countries
South Korea
Outcome results
None listed