NCT07364877

Brief Summary

Safety and pharmacokinetic characteristics evaluation of DW4421 and DW4421S

Trial Health

75
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
1mo left

Started Dec 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress93%
Dec 2025May 2026

Study Start

First participant enrolled

December 28, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2026

Expected
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 6, 2026

Last Update Submit

January 18, 2026

Conditions

Healthy Adult Volunteer

Outcome Measures

Primary Outcomes (2)

  • Cmax

    up to 48 hour

  • AUC0-t

    up to 48 hour

Study Arms (2)

Sequence A

EXPERIMENTAL

cross-over

Drug: DW4421Drug: DW4421S

Sequence B

EXPERIMENTAL

Cross-over

Drug: DW4421Drug: DW4421S

Interventions

DW4421DRUG

DW4421 or DW4421S

Sequence ASequence B
DW4421SDRUG

DW4421 or DW4421S

Sequence ASequence B

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
  • Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive)

You may not qualify if:

  • 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

Location

Study Design

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

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 23, 2026

Study Start

December 28, 2025

Primary Completion

March 19, 2026

Study Completion (Estimated)

May 18, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

KR(1)