NCT06592495

Brief Summary

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2024

Longer than P75 for phase_1 healthy-volunteers

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

First Submitted

Initial submission to the registry

August 28, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

August 28, 2024

Last Update Submit

September 19, 2024

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • The maximum serum concentration(Cmax) of DWJ1589 and DWC202315

    Cmax of DWJ1589 and DWC202315

    At pre-dose (0 hour), and post-dose 0.83 to 72 hour.

  • The Area under the curve(AUC)last of DWJ1589 and DWC202315

    AUClast of DWJ1589 and DWC202315

    At pre-dose (0 hour), and post-dose 0.83 to 72 hour.

Study Arms (2)

Sequence A: RTRT

EXPERIMENTAL

T: DWJ1589 R: DWC202315

Drug: Period 1Drug: Period 2Drug: Period 3Drug: Period 4

Sequence B: TRTR

EXPERIMENTAL

T: DWJ1589 R: DWC202315

Drug: Period 1Drug: Period 2Drug: Period 3Drug: Period 4

Interventions

Period 1DRUG

DWJ1589 or DWC202315

Sequence A: RTRTSequence B: TRTR
Period 2DRUG

DWJ1589 or DWC202315

Sequence A: RTRTSequence B: TRTR
Period 3DRUG

DWJ1589 or DWC202315

Sequence A: RTRTSequence B: TRTR
Period 4DRUG

DWJ1589 or DWC202315

Sequence A: RTRTSequence B: TRTR

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 Officials

  • KANG, MD, PhD

    H Plus Yangji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SHIN, CPL

CONTACT

02-550-8858

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 28, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

January 1, 2025

Study Completion

October 1, 2025

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share