Multiple Ascending Dose Study of DW4421

July 2, 2026 updated by: Daewon Pharmaceutical Co., Ltd.

A Phase 1 Clinical Trial to Evaluate the Safety, the Pharmacokinetics and Pharmacodynamics After Multiple Administration of DW4421 in Healthy Adult Volunteers

Multiple Ascending Dose of DW4421, phase I

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea
        • Chungbuk National University Hospital
        • Contact:
          • Chungbuk National University Hospital
          • Phone Number: +82-43-269-6771
          • Email: cbnuhirb@naver.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cohort 1 (DW4421S 5mg)
DW4421S-T0, 1 tablet will be orally administered in BID for 7days
Drug: DW4421S-T0
DW4421 5mg
Experimental: cohort 2 (DW4421S 10mg)
DW4421S-T0, 1 tablet will be orally administered in QD for 7days
Drug: DW4421S-T0
DW4421 5mg
Experimental: cohort 3 (DW4421S 15mg)
DW4421S-T2, 1 tablet will be orally administered in QD for 7days
Drug: DW4421S-T2
DW4421 15mg
Experimental: cohort 4 (DW4421S 20mg)
DW4421S-T1, 1 tablet will be orally administered in QD for 7days
Drug: DW4421S-T1
DW4421 20mg
Experimental: cohort 5 (DW4421S 30mg)
DW4421S-T3, 1 tablet will be orally administered in QD for 7days
Drug: DW4421S-T3
DW4421 30mg
Experimental: cohort 6 (DW4421S 40mg)
DW4421S, 1 tablet will be orally administered in QD for 7days
Drug: DW4421S
DW4421 40mg
Active Comparator: cohort 7 (Zastaprazan 20mg)
DW4421-3, 1 tablet will be orally administered in QD for 7days
Drug: DW4421-3
Zastaprazan 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCτ,ss, Area under the drug concentration-time curve of DW4421 following multiple oral administration
Time Frame: Day 7
Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration
Day 7
Cmax of DW4421 following multiple oral administration
Time Frame: Day 7
Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • DW4421-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A decision on whether to share individual participant data has not yet been made. We plan to evaluate the feasibility of data sharing after the study is completed and the primary results are published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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