NCT07364838

Brief Summary

A Randomized, Open-label, Oral in healthy volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 21, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
Last Updated

January 23, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 22, 2025

Last Update Submit

January 18, 2026

Conditions

GERD (Gastroesophageal Reflux Disease)

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    Cmax of DW4421

    up to 48 hours

  • Area under the plasma concentration versus time curve (AUC)

    AUC of DW4421

    up to 48 hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Cross-over

Drug: DW4421

Sequence B

EXPERIMENTAL

Cross-over

Drug: DW4421

Interventions

DW4421DRUG

DW4421 on fasted or fed condition

Sequence ASequence B

Eligibility Criteria

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

You may qualify if:

  • Healthy Volunteers who are ≥19 years old
  • Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2

You may not qualify if:

  • Clinically significant Medical History
  • In the case of women, pregnant(Urine-HCG positive) or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

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

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 23, 2026

Study Start

November 21, 2024

Primary Completion

April 8, 2025

Study Completion

April 8, 2025

Last Updated

January 23, 2026

Record last verified: 2025-12

Locations

KR(1)