NCT07343245

Brief Summary

Drug-Drug Interaction between DW4421 and three different kinds of NSAIDs

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
2mo left

Started Dec 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Dec 2025Jun 2026

Study Start

First participant enrolled

December 1, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2026

Expected
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

December 22, 2025

Last Update Submit

January 6, 2026

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss

    Baseline to Day 13 or Day 15

  • AUCτ,ss

    Baseline to Day 13 or Day 15

Study Arms (6)

Cohort 1, A

EXPERIMENTAL
Drug: DW4421Drug: DW4421-N1

Cohort 1, B

EXPERIMENTAL
Drug: DW4421Drug: DW4421-N1

Cohort 2, C

EXPERIMENTAL
Drug: DW4421Drug: DW4421-N2

Cohort 2, D

EXPERIMENTAL
Drug: DW4421Drug: DW4421-N2

Cohort 3, E

EXPERIMENTAL
Drug: DW4421Drug: DW4421-N3

Cohort 3, F

EXPERIMENTAL
Drug: DW4421Drug: DW4421-N3

Interventions

DW4421DRUG

QD

Cohort 1, ACohort 1, BCohort 2, CCohort 2, DCohort 3, ECohort 3, F
DW4421-N1DRUG

BID

Cohort 1, ACohort 1, B
DW4421-N2DRUG

BID

Cohort 2, CCohort 2, D
DW4421-N3DRUG

QD

Cohort 3, ECohort 3, F

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
  • Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

You may not qualify if:

  • Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

RECRUITING

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 15, 2026

Study Start

December 1, 2025

Primary Completion

February 22, 2026

Study Completion (Estimated)

June 17, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

KR(1)