SB17170 Phase1 Trial in Healthy Volunteer

NCT05795192 | Completed Phase 1

• 1 other identifier: SMARTT-002
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety Issues; Tolerability; Pharmacokinetics; Pharmacodynamics

Keywords

HMGB1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

• 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

• The maximum (or peak) serum concentration(Cmax)

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

• The time to reach Cmax(Tmax)

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

• 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

Study Arms (18)

SB17170 of 50mg, Single dose

EXPERIMENTAL

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 50mg capsule, QD for 1 day(single).

Drug: SB17170

Placebo of 50mg, Single dose

PLACEBO COMPARATOR

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 50mg, QD for 1 day(single).

Drug: Placebo

SB17170 of 150mg, Single dose

EXPERIMENTAL

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 100mg and 50mg capsules, QD for 1 day(single).

Drug: SB17170

Placebo of 150mg, Single dose

PLACEBO COMPARATOR

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 100mg and 50mg capsules, QD for 1 day(single).

Drug: Placebo

SB17170 of 250mg, Single dose

EXPERIMENTAL

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg capsule, QD for 1 day(single).

Drug: SB17170

Placebo of 250mg, Single dose

PLACEBO COMPARATOR

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg capsule, QD for 1 day(single).

Drug: Placebo

SB17170 of 500mg, Single dose, Food-effect

EXPERIMENTAL

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 2 capsules, QD for 1 day(single). Food-effect test for the expected efficacy dose * 1st period without a meal * Wash out period more than 7 days * 2nd period with a high-fat meal

Drug: SB17170

Placebo of 500mg, Single dose, Food-effect

PLACEBO COMPARATOR

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 2 capsules, QD for 1 day(single). Food-effect test for the expected efficacy dose * 1st period without a meal * Wash out period more than 7 days * 2nd period with a high-fat meal

Drug: Placebo

SB17170 of 1000mg, Single dose

EXPERIMENTAL

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 4capsules, QD for 1 day(single).

Drug: SB17170

Placebo of 1000mg, Single dose

PLACEBO COMPARATOR

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 4 capsules, QD for 1 day(single).

Drug: Placebo

SB17170 of 1500mg, Single dose

EXPERIMENTAL

Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 6 capsules, QD for 1 day(single).

Drug: SB17170

Placebo of 1500mg, Single dose

PLACEBO COMPARATOR

Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg 6 capsules, QD for 1 day(single).

Drug: Placebo

SB17170 of 250mg, Multiple dose for 7days

EXPERIMENTAL

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 1 capsule, QD for 7 days(multiple).

Drug: SB17170

Placebo of 250mg, Multiple dose for 7days

PLACEBO COMPARATOR

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 1 capsule, QD for 7 days(multiple).

Drug: Placebo

SB17170 of 500mg, Multiple dose for 7days

EXPERIMENTAL

Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 2 capsules, QD for 7 days(multiple).

Drug: SB17170

Placebo of 500mg, Multiple dose for 7days

PLACEBO COMPARATOR

Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 2 capsules, QD for 7 days(multiple).

Drug: Placebo

SB17170 of 1000mg, Multiple dose for 7days

EXPERIMENTAL

Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 4 capsules, QD for 7 days(multiple).

Drug: SB17170

Placebo of 1000mg, Multiple dose for 7days

PLACEBO COMPARATOR

Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 4 capsules, QD for 7 days(multiple).

Drug: Placebo

Interventions

SB17170 DRUG

Taking SB17170 orally once a day

SB17170 of 1000mg, Multiple dose for 7days; SB17170 of 1000mg, Single dose; SB17170 of 1500mg, Single dose; SB17170 of 150mg, Single dose; SB17170 of 250mg, Multiple dose for 7days; SB17170 of 250mg, Single dose; SB17170 of 500mg, Multiple dose for 7days; SB17170 of 500mg, Single dose, Food-effect; SB17170 of 50mg, Single dose

Placebo DRUG

Taking Placebo orally once a day

Placebo of 1000mg, Multiple dose for 7days; Placebo of 1000mg, Single dose; Placebo of 1500mg, Single dose; Placebo of 150mg, Single dose; Placebo of 250mg, Multiple dose for 7days; Placebo of 250mg, Single dose; Placebo of 500mg, Multiple dose for 7days; Placebo of 500mg, Single dose, Food-effect; Placebo of 50mg, Single dose

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SPARK Biopharma: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Officials

• SeungHwan Lee, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Block randomized, double-blind design controlling with IWRS
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 3, 2023
• Study Start: May 24, 2023
• Primary Completion: February 29, 2024
• Study Completion: March 15, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)