NCT07349589

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
7mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

January 7, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

27 days

First QC Date

January 7, 2026

Last Update Submit

January 14, 2026

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (2)

  • AUC0-t

    Pharmacodynamic DW5524

    up to 8 hour

  • Cmax

    Pharmacodynamic DW5524

    up to 8 hour

Study Arms (4)

Group1

EXPERIMENTAL

Group1

Drug: DW5524

Group2

EXPERIMENTAL

Group2

Drug: DW5524

Group3

EXPERIMENTAL

Group3

Drug: DW5524

Group4

EXPERIMENTAL

Group4

Drug: DW5524-A

Interventions

DW5524DRUG

DW5524

Group1Group2Group3
DW5524-ADRUG

DW5524-A

Group4

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 20, 2026

Study Start

February 1, 2026

Primary Completion

February 28, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

KR(1)