NCT06010589

Brief Summary

This study aims to compare the pharmacokinetics and safety following administration of DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

August 17, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

August 20, 2023

Last Update Submit

August 28, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss of DWJ1558

    Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1558

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

  • AUCt of DWJ1558

    Area under the curve from the time of dosing to the last measurable concentration(AUCt) of DWJ1558

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

Study Arms (2)

Intervention: DWJ1558

EXPERIMENTAL
Drug: DWJ1558

Intervention: DWC202310 and DWC202311

EXPERIMENTAL
Drug: DWC202310 and DWC202311

Interventions

DWJ1558DRUG

DWJ1558

Intervention: DWJ1558
DWC202310 and DWC202311DRUG

Co-administration of DWC202310 and DWC202311

Intervention: DWC202310 and DWC202311

Eligibility Criteria

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

You may qualify if:

  • over 19 year old

You may not qualify if:

  • Pancreatitis
  • Diabetic ketoacidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus YANGJI Hospital

Seoul, South Korea

Location

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, 2023

First Posted

August 24, 2023

Study Start

August 17, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

KR(1)