Evaluate the Safety, Tolerability and Pharmacokinetics of DW5524 in Healthy Adult Volunteers

This study aimed to evaluate the safety and pharmacokinetic characteristics of DW5524 in healthy adult volunteers.

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Key information

Conditions

Healthy Adult

Age range

19 year and older

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 volunteers aged 19 years or older at the time of screening
Individuals weighing 50.0 kg or more and having a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening

Exclusion criteria

Those with a current or past medical history of clinically significant liver, kidney, nervous, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, or musculoskeletal diseases.

Treatment and study plan

DW5524

Drug

DW5524

DW5524-A

Drug

DW5524-A

Primary outcomes

AUC0-t

Time frame: up to 8 hour

Pharmacodynamic DW5524
Cmax

Time frame: up to 8 hour

Pharmacodynamic DW5524

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Single-dose, Parallel-design, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of DW5524 in Healthy Adult Volunteers

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 20, 2026
Registry last updated: Jan 20, 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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