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Enrolling by Invitation

NCT Number: NCT07364877

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

Safety and pharmacokinetic characteristics evaluation of DW4421 and DW4421S

Enrolling by Invitation

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Key information

Conditions

Healthy Adult Volunteer

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chungbuk National University Hospital

Cheongju-si, South Korea

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
  • 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

Treatment and study plan

DW4421

Drug

DW4421 or DW4421S

DW4421S

Drug

DW4421 or DW4421S

Primary outcomes

  1. Cmax

    Time frame: up to 48 hour

  2. AUC0-t

    Time frame: up to 48 hour

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 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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