Pharmacokinetics Clinical Trial
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
Verified date | March 2024 |
Source | SPARK Biopharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | March 15, 2024 |
Est. primary completion date | February 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
SPARK Biopharma |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | The maximum (or peak) serum concentration(Cmax) | Pharmacokinetic parameter | Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour | |
Secondary | The time to reach Cmax(Tmax) | Pharmacokinetic parameter | Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour | |
Secondary | 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 | |
Secondary | The ratio of oral clearance(CL/F) | Pharmacokinetic parameter | Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour | |
Secondary | The Renal clearance(CLR) | Pharmacokinetic parameter | Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour | |
Secondary | The volume of distribution(vd/f) | Pharmacokinetic parameter | Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour | |
Secondary | 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 | |
Secondary | Compare the concentrations of TNF-a between the active and placebo groups | Tumor Necrosis Factor-alpha human(TNF-a) as a Pharmacodynamic parameter | Baseline 0 hour, 1.5hour, 24hour, | |
Secondary | Compare the concentratiosn of Interleukin-6 between the active and placebo groups | Interleukin-6 as a Pharmacodynamic parameter | Baseline 0 hour, 1.5hour, 24hour, |
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