Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers

June 3, 2026 updated by: Daewoong Pharmaceutical Co. LTD.

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers

The safety and tolerability of single and multiple administration of DWP212525

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The safety and tolerability of single and multiple administration of DWP212525 will be evaluated in healthy adult volunteers.

Study Type

Interventional

Enrollment (Estimated)

84

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
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy adult volunteers aged 19 to 55 years
  2. Those with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 30.0 kg/m2
  3. Received a sufficient explanation on this study
  4. Eligible as subjects in the study

Exclusion Criteria:

  1. History of diseases such as clinically significant disease of hepatobiliary
  2. Following conditions applicable to clinically significant acute or chronic infections or the past history confirmed via an interview
  3. Hemato-oncologic diseases, including malignant tumor diagnosis
  4. Past history of tuberculosis infection or confirmed tuberculosis in the IGRA test and chest X-ray test

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: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 11
Drug: DWP212525 placebo
DWP212525 placebo
Drug: DWP212525 XXmg
DWP212525 XXmg
Experimental: Cohort1
Drug: DWP212525 placebo
DWP212525 placebo
Drug: DWP212525 XXmg
DWP212525 XXmg
Experimental: Cohort2
Drug: DWP212525 placebo
DWP212525 placebo
Drug: DWP212525 XXmg
DWP212525 XXmg
Experimental: Cohort3
Drug: DWP212525 placebo
DWP212525 placebo
Drug: DWP212525 XXmg
DWP212525 XXmg
Experimental: Cohort4
Drug: DWP212525 placebo
DWP212525 placebo
Drug: DWP212525 XXmg
DWP212525 XXmg
Experimental: Cohort5
Drug: DWP212525 placebo
DWP212525 placebo
Drug: DWP212525 XXmg
DWP212525 XXmg
Experimental: Cohort6
Drug: DWP212525 placebo
DWP212525 placebo
Drug: DWP212525 XXmg
DWP212525 XXmg
Experimental: Cohort7
Drug: DWP212525 placebo
DWP212525 placebo
Drug: DWP212525 XXmg
DWP212525 XXmg
Experimental: Cohort8
Drug: DWP212525 placebo
DWP212525 placebo
Drug: DWP212525 XXmg
DWP212525 XXmg
Experimental: Cohort9
Drug: DWP212525 placebo
DWP212525 placebo
Drug: DWP212525 XXmg
DWP212525 XXmg
Experimental: Cohort10
Drug: DWP212525 placebo
DWP212525 placebo
Drug: DWP212525 XXmg
DWP212525 XXmg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK profiles of DWP212525
Time Frame: Day 1
Area under the plasma drug concentration-time curve from 0 to last
Day 1
PK profiles of DWP212525
Time Frame: Day 1
The maximum or peak concentration between zero and dosing interval
Day 1
PK profiles of DWP212525
Time Frame: Day 1
Time of maximum concentration
Day 1
Safety profiles
Time Frame: Day 1
AE, SAE, etc.
Day 1

Collaborators and Investigators

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

Sponsor

Daewoong 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 (Actual)

December 10, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

December 16, 2024

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWP212525101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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