NCT07144176

Brief Summary

PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

August 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

Same day

First QC Date

August 20, 2025

Last Update Submit

August 27, 2025

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma drug concentration-time curve [AUCt]

    Area under the plasma drug concentration-time curve \[AUCt\] of DWJ1511 and DWC202501

    0-12 Hours

  • Maximum plasma concentration [Cmax]

    Maximum plasma concentration \[Cmax\] of DWJ1511 and DWC202501

    0-12 Hours

Secondary Outcomes (1)

  • Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]

    0-12 Hours

Study Arms (2)

A(RT)

EXPERIMENTAL

30 Subjects, Cross-over, Single dose DWC202501 on period 1, Single dose of DWJ1511 on period 2

Drug: DWJ1511Drug: DWC202501

B(TR)

ACTIVE COMPARATOR

30 Subjects, Cross-over, Single dose DWJ1511 on period 1, Single dose of DWC202501 on period 2

Drug: DWJ1511Drug: DWC202501

Interventions

DWJ1511DRUG

Test drug: DWJ1511

A(RT)B(TR)
DWC202501DRUG

Comparator: DWC202501

A(RT)B(TR)

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female participants aged ≥19 years and \<65 years at the time of screening
  • Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight \[kg\] / height \[m\]²)

You may not qualify if:

  • Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.
  • Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus Yangji Hospital

Seoul, 08779, South Korea

RECRUITING

Central Study Contacts

Kang

CONTACT

82) 070-4665-9490juspa@newyjh.com

Study Design

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

Study Record Dates

First Submitted

August 20, 2025

First Posted

August 27, 2025

Study Start

September 1, 2025

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)