SB17170 Phase1 Trial in Healthy Volunteer

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05795192
• Other study ID #: SMARTT-002
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Pharmacodynamics
• Pharmacokinetics
• Safety Issues
• Tolerability

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,