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Completed

NCT Number: NCT05795192

SB17170 Phase1 Trial in Healthy Volunteer

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.

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Key information

Conditions

Safety Issues Pharmacodynamics Pharmacokinetics Tolerability

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SB17170

Drug

Taking SB17170 orally once a day

Placebo

Drug

Taking Placebo orally once a day

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 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 outcomes

  1. The Area Under the Curve from dosing to the time of the last measured concentration

    Time frame: Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour

    Pharmacokinetic parameter

  2. The area under the curve from time 0 extrapolated to infinite time(AUCinf)

    Time frame: Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour

    Pharmacokinetic parameter

  3. The maximum (or peak) serum concentration(Cmax)

    Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour

    Pharmacokinetic parameter

  4. The time to reach Cmax(Tmax)

    Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour

    Pharmacokinetic parameter

  5. The Half life(t1/2) of SB17170 and active metabolite

    Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour

    Pharmacokinetic parameter

  6. The ratio of oral clearance(CL/F)

    Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour

    Pharmacokinetic parameter

  7. The Renal clearance(CLR)

    Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour

    Pharmacokinetic parameter

  8. The volume of distribution(vd/f)

    Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour

    Pharmacokinetic parameter

  9. The ratio of unchanged drug to metabolite(Metabolic ratio)

    Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour

    Pharmacokinetic parameter

  10. Compare the concentrations of TNF-α between the active and placebo groups

    Time frame: Baseline 0 hour, 1.5hour, 24hour,

    Tumor Necrosis Factor-alpha human(TNF-α) as a Pharmacodynamic parameter

  11. Compare the concentratiosn of Interleukin-6 between the active and placebo groups

    Time frame: Baseline 0 hour, 1.5hour, 24hour,

    Interleukin-6 as a Pharmacodynamic parameter

Sponsors and collaborators

Lead sponsor

SPARK Biopharma

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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