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

NCT06846684 | Completed Phase 1

• 1 other identifier: SMARTT-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Cmax of SB_MDZ

  Day 0, 6, 15

• AUC of SB_MDZ

  Day 0, 6, 15

Secondary Outcomes (5)

• 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

Study Arms (1)

SB17170 + SB_MDZ

EXPERIMENTAL

Drug: SB17170; Drug: SB_MDZ

Interventions

SB17170 DRUG

PO, QD

SB17170 + SB_MDZ

SB_MDZ DRUG

IV

SB17170 + SB_MDZ

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• SPARK Biopharma: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 26, 2025
• Study Start: March 27, 2025
• Primary Completion: June 10, 2025
• Study Completion: September 12, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)