SB17170 Phase1 Trial in Healthy Volunteer

SPARK Biopharma

Status and phase: Completed; Phase 1

Conditions: Pharmacodynamics; Safety Issues; Tolerability; Pharmacokinetics

Treatments: Drug: Placebo; Drug: SB17170

Study type: Interventional

Funder types: Industry

Identifiers

NCT05795192

SMARTT-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 18 patient groups, including a placebo group

SB17170 of 50mg, Single dose

Experimental group

Description:

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

Treatment:

Drug: SB17170

Placebo of 50mg, Single dose

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

SB17170 of 150mg, Single dose

Experimental group

Description:

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

Treatment:

Drug: SB17170

Placebo of 150mg, Single dose

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

SB17170 of 250mg, Single dose

Experimental group

Description:

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

Treatment:

Drug: SB17170

Placebo of 250mg, Single dose

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

SB17170 of 500mg, Single dose, Food-effect

Experimental group

Description:

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

Treatment:

Drug: SB17170

Placebo of 500mg, Single dose, Food-effect

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

SB17170 of 1000mg, Single dose

Experimental group

Description:

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

Treatment:

Drug: SB17170

Placebo of 1000mg, Single dose

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

SB17170 of 1500mg, Single dose

Experimental group

Description:

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

Treatment:

Drug: SB17170

Placebo of 1500mg, Single dose

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

SB17170 of 250mg, Multiple dose for 7days

Experimental group

Description:

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

Treatment:

Drug: SB17170

Placebo of 250mg, Multiple dose for 7days

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

SB17170 of 500mg, Multiple dose for 7days

Experimental group

Description:

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

Treatment:

Drug: SB17170

Placebo of 500mg, Multiple dose for 7days

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

SB17170 of 1000mg, Multiple dose for 7days

Experimental group

Description:

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

Treatment:

Drug: SB17170

Placebo of 1000mg, Multiple dose for 7days

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo