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

January 14, 2026 updated by: Daewon Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Cheongju-si, South Korea
        • Chungbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group1
Drug: DW5524
DW5524
Experimental: Group2
Drug: DW5524
DW5524
Experimental: Group3
Drug: DW5524
DW5524
Experimental: Group4
Drug: DW5524-A
DW5524-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-t
Time Frame: up to 8 hour
Pharmacodynamic DW5524
up to 8 hour
Cmax
Time Frame: up to 8 hour
Pharmacodynamic DW5524
up to 8 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • DW5524-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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