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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05795192
Other study ID # SMARTT-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 24, 2023
Est. completion date March 15, 2024

Study information

Verified date March 2024
Source SPARK Biopharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
SB17170
Taking SB17170 orally once a day
Placebo
Taking Placebo orally once a day

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
SPARK Biopharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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