Enrolling by invitationNCT07364877Updated Jan 23, 2026

A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DW4421 and DW4421S in Healthy Adult Volunteers

A Phase 1 interventional study of DW4421 and DW4421S in Healthy Adult Volunteer, sponsored by Daewon Pharmaceutical Co., Ltd.. Enrolling by invitation at 1 site in South Korea. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Daewon Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Basic science

From the registry’s dates

Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as enrolling by invitation.

Phase: Phase 1
Study type: Interventional
Enrollment: 38
Allocation: Randomized
Ages: 19 Years to 50 Years
Sex: All

Study summary

Safety and pharmacokinetic characteristics evaluation of DW4421 and DW4421S

Conditions studied

Healthy Adult Volunteer

In context

Lead sponsor

Daewon Pharmaceutical Co., Ltd. is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 38 participants (estimated)

Study arms

Experimental
Sequence A
cross-over
Drug: DW4421 · Drug: DW4421S
Experimental
Sequence B
Cross-over
Drug: DW4421 · Drug: DW4421S

Interventions

DrugDW4421
DW4421 or DW4421S
DrugDW4421S
DW4421 or DW4421S

What researchers measure

Primary outcomes

Cmax
Time frame: up to 48 hour
AUC0-t
Time frame: up to 48 hour

Study locations

1 site

Chungbuk National University Hospital
Cheongju-si, South Korea

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07364877
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Jan 23, 2026
Start date: Dec 28, 2025
Primary completion: Mar 19, 2026 (estimated)
Completion: May 18, 2026 (estimated)
Last update: Jan 23, 2026

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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Daewon Pharmaceutical Co., Ltd.

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