NCT07267221

Brief Summary

This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fed conditions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
0mo left

Started Dec 2025

Typical duration for phase_1 healthy-volunteers

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

Study Progress96%
Dec 2025May 2026

First Submitted

Initial submission to the registry

November 16, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

November 16, 2025

Last Update Submit

December 3, 2025

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Cmax of DWJ1622 and DWC202313, DWC202314

    At pre-dose (0 hours), and post-dose 1 to 72 hours.

  • AUClast

    AUClast of DWJ1622 and DWC202313, DWC202314

    Time Frame: At pre-dose (0 hours), and post-dose 1 to 72 hours.

Secondary Outcomes (3)

  • AUCinf

    At pre-dose (0 hours), and post-dose 1 to 72 hours.

  • AUClast/AUCinf

    At pre-dose (0 hours), and post-dose 1 to 72 hours.

  • Tmax

    At pre-dose (0 hours), and post-dose 1 to 72 hours.

Study Arms (2)

DWJ1622

EXPERIMENTAL
Drug: DWJ1622Drug: DWC202313, DWC202314

DWC202313, DWC202314

EXPERIMENTAL
Drug: DWJ1622Drug: DWC202313, DWC202314

Interventions

DWJ1622DRUG

DWJ1622 (single oral dose) is administered in accordance with the study protocol.

DWC202313, DWC202314DWJ1622
DWC202313, DWC202314DRUG

DWC202313, DWC202314(single oral dose) is administered in accordance with the study protocol.

DWC202313, DWC202314DWJ1622

Eligibility Criteria

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

You may qualify if:

  • Over 19 year old
  • Healthy adult volunteers

You may not qualify if:

  • with a history of mental disorder
  • For female volunteers, those who are suspected of being pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus YANGJI Hospital

Seoul, Gwanak-gu, 08779, South Korea

RECRUITING

Central Study Contacts

SHIN

CONTACT

825508858hbshin028@daewoong.co.kr

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

November 16, 2025

First Posted

December 5, 2025

Study Start

December 1, 2025

Primary Completion

January 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

December 5, 2025

Record last verified: 2025-12

Locations

KR(1)