Multiple Ascending Dose Study of DW4421

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07691242

Enrollment

Registered

2026-07-08

Start date

2026-09-01

Completion date

2027-02-01

Last updated

2026-07-08

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

Conditions

Healthy Adult Volunteers

Brief summary

Multiple Ascending Dose of DW4421, phase I

Interventions

DRUGDW4421S-T0

DW4421 5mg

DRUGDW4421S-T2

DW4421 15mg

DRUGDW4421S-T1

DW4421 20mg

DRUGDW4421S-T3

DW4421 30mg

DRUGDW4421S

DW4421 40mg

DRUGDW4421-3

Zastaprazan 20mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

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, 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026