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CompletedNCT06846684Updated Nov 19, 2025

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

A Phase 1 interventional study of SB17170 and SB_MDZ in Drug Drug Interaction (DDI), sponsored by SPARK Biopharma. Completed at 1 site in South Korea. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by SPARK Biopharma · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
19 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Drug Drug Interaction (DDI)
03

In context

Lead sponsor

SPARK Biopharma is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    SB17170 + SB_MDZ

    Drug: SB17170 · Drug: SB_MDZ

Interventions

  • DrugSB17170

    PO, QD

  • DrugSB_MDZ

    IV

06

What researchers measure

Primary outcomes

  1. Cmax of SB_MDZ

    Time frame: Day 0, 6, 15

  2. AUC of SB_MDZ

    Time frame: Day 0, 6, 15

Secondary outcomes

  1. Tmax of SB_MDZ

    Time frame: Day 0, 6, 15

  2. AUCinf of SB_MDZ

    Time frame: Day 0, 6, 15

  3. T1/s of SB_MDZ

    Time frame: Day 0, 6, 15

  4. CL of SB_MDZ

    Time frame: Day 0, 6, 15

  5. Vz of SB_MDZ

    Time frame: Day 0, 6, 15

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06846684
Lead sponsor
SPARK Biopharma
Responsible party
Sponsor
First posted
Feb 26, 2025
Start date
Mar 27, 2025
Primary completion
Jun 10, 2025
Completion
Sep 12, 2025
Last update
Nov 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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