NCT05954338

Brief Summary

This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy 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 Aug 2023

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

First Submitted

Initial submission to the registry

July 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 12, 2023

Last Update Submit

July 21, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543

    At pre-dose (0 hour), and post-dose 1 to 120 hour.

  • Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543

    At pre-dose (0 hour), and post-dose 1 to 120 hour.

Study Arms (2)

Intervention: DWC202307 + DWJ1543

EXPERIMENTAL
Drug: DWC202307Drug: DWJ1543

Intervention: DWC202307 + DWC202216

EXPERIMENTAL
Drug: DWC202307Drug: DWC202216

Interventions

DWC202307DRUG

DWC202307

Intervention: DWC202307 + DWC202216Intervention: DWC202307 + DWJ1543
DWJ1543DRUG

DWJ1543

Intervention: DWC202307 + DWJ1543
DWC202216DRUG

DWC202216

Intervention: DWC202307 + DWC202216

Eligibility Criteria

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

You may qualify if:

  • Over 19 year old
  • Healthy adult volunteer

You may not qualify if:

  • Eye disorders including cataracts
  • Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

July 12, 2023

First Posted

July 20, 2023

Study Start

August 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

July 24, 2023

Record last verified: 2023-07