Multiple Ascending Dose Study of DW4421

NCT07691242 — Phase 1, Not yet recruiting, 56 participants, Daewon Pharmaceutical Co., Ltd.

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

Registry	NCT07691242
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: none, basic science
Enrollment	56 (Estimated)
Sponsor	Daewon Pharmaceutical Co., Ltd. (Industry)
Conditions	Healthy Adult Volunteers
Interventions	DW4421S-T0, DW4421S-T2, DW4421S-T1, DW4421S-T3, DW4421S, DW4421-3 (Drug)
Dates	start 2026-09-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-02-01 (estimated), first posted 2026-07-08, last updated 2026-07-08
Locations	1 site in South Korea

-Summary

Multiple Ascending Dose of DW4421, phase I

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+Arms and interventions

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

DW4421S-T0 (Drug): DW4421 5mg
DW4421S-T2 (Drug): DW4421 15mg
DW4421S-T1 (Drug): DW4421 20mg
DW4421S-T3 (Drug): DW4421 30mg
DW4421S (Drug): DW4421 40mg
DW4421-3 (Drug): Zastaprazan 20mg

+Outcome measures

Primary outcomes

AUCτ,ss, Area under the drug concentration-time curve of DW4421 following multiple oral administration [Day 7]: Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration
Cmax of DW4421 following multiple oral administration [Day 7]: Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration

+Eligibility

Sex: All, ages: 19 Years to 50 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Chungbuk National University Hospital	Cheongju-si, North Chungcheong	South Korea