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

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

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.

Study Overview

• Status: Completed
• Conditions: Drug Drug Interaction (DDI)
• Intervention / Treatment: Drug: SB17170; Drug: SB_MDZ

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SB17170 + SB_MDZ	Drug: SB17170; PO, QD; Drug: SB_MDZ; IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of SB_MDZ	Day 0, 6, 15
AUC of SB_MDZ	Day 0, 6, 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax of SB_MDZ	Day 0, 6, 15
AUCinf of SB_MDZ	Day 0, 6, 15
T1/s of SB_MDZ	Day 0, 6, 15
CL of SB_MDZ	Day 0, 6, 15
Vz of SB_MDZ	Day 0, 6, 15

Collaborators and Investigators

• Sponsor: SPARK Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Actual): June 10, 2025
• Study Completion (Actual): September 12, 2025

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SMARTT-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No