A Open-label, Drug-Drug Interaction With SB_MDZ in Healty Adult Subjects

NCT ID: NCT06846684

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-27
• Study Completion Date: 2025-09-12

Brief Summary

This clinical trial is a phase 1, open-label, fixed-sequence, drug-drug interaction study to investigate the effect of single and multiple oral doses of SB17170 on the pharmacokinetics of SB_MDZ in healthy adult subjects.

Conditions

Drug Drug Interaction (DDI)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SB17170 + SB_MDZ

Group Type: EXPERIMENTAL

SB17170

Intervention Type: DRUG

PO, QD

SB_MDZ

Intervention Type: DRUG

IV

Interventions

SB17170

PO, QD

Intervention Type: DRUG

SB_MDZ

IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy adult subjects aged 19 to 50 years at the time of written consent.

2. Individuals with a body weight of ≥ 50.0 kg, and a Body Mass Index(BMI) of ≥ 18.0 kg/m2 and < 30.0 kg/m2 at the time of screening ☞ BMI(kg/m2) = weight(kg) / {height(m)}2

3. Individuals who have voluntarily provided written consent to participate in the trial, after being fully informed about the study and agreeing to follow all precautions associated with participation.

Exclusion Criteria

1. Individuals with a clinically significant disease or history in hepatobiliary, renal, nervous, respiratory, immune, hemato-oncology, cardiovascular, urinary system, or psychiatric disorder

2. Individuals with a history of a gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc) or surgeries (except for simple appendectomy or hernia surgery) that may affect the safety and pharmacokinetic assessment of the investigational product (IP)

3. Individuals with hypersensitivity or significant history of hypersensitivity to drugs, including ingredients of the IP (SB17170 or its metabolite SB1703, SB_MDZ, and benzodiazepine-class drugs) or other drugs (e.g., aspirin, antibiotics)

4. Individuals with a current or historical condition that may increase risk, as determined by the investigator or as indicated in SB_MDZ's product information

5. Individuals who exhibited one or more of the following results in clinical laboratory tests during the screening, including additional tests

• AST (SGOT), ALT (SGPT) > 60 IU/L
• Estimated glomerular filtration rate (eGFR, CKD-EPI equation): < 60 mL/min/1.73m2
• Individuals with a positive result on serology tests (heapatitis B, hepatitis C, human immunodeficiency virus (HIV) and syphilis tests)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SPARK Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SMARTT-003

Identifier Type: -

Identifier Source: org_study_id