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NCT Number: NCT07691242

Multiple Ascending Dose Study of DW4421

Multiple Ascending Dose of DW4421, phase I

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Key information

Conditions

Healthy Adult Volunteers

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Location contact

Chungbuk National University Hospital

CONTACT

[email protected]

+82-43-269-6771

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. Cmax of DW4421 following multiple oral administration

    Time frame: Day 7

    Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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