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

A Randomized, Open-label, Single-dose, 2-sequence, Two-period, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW4421 and DW4421S in Healthy Adult Volunteers

Status

Enrolling by invitation

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07364877

Enrollment

Registered

2026-01-23

Start date

2025-12-28

Completion date

2026-05-18

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Volunteer

Brief summary

Safety and pharmacokinetic characteristics evaluation of DW4421 and DW4421S

Interventions

DRUGDW4421

DW4421 or DW4421S

DRUGDW4421S

DW4421 or DW4421S

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

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

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026