NCT07007520

Brief Summary

This study will evaluate the food effect on the pharmacokinetics of DA-5223 in healthy adult subjects

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 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

May 28, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

Same day

First QC Date

May 28, 2025

Last Update Submit

August 13, 2025

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (2)

  • AUC-last

    Area under the plasma concentration-time curve up to the last measurable concentration

    0~12 hours

  • Cmax

    Peak Plasma Concentration

    0~12 hours

Study Arms (2)

Sequence A

EXPERIMENTAL
Drug: DA-5223(Fasting)Drug: DA-5223(Fed)

Sequence B

EXPERIMENTAL
Drug: DA-5223(Fasting)Drug: DA-5223(Fed)

Interventions

DA-5223(Fasting)DRUG

once a day

Sequence ASequence B
DA-5223(Fed)DRUG

once a day

Sequence ASequence B

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult male or female, 19 years to 55 years
  • Male weighing 50 kg or more, female weighing 45 kg or more with a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2
  • The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate

You may not qualify if:

  • The subjects with acute illness
  • The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product
  • The subjects hypersensitive to any of the Investigational Product components or other drug components
  • The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
  • The subjects who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Global Clinical Trials Center

Seongnam-si, Gyeonggi-do, 13520, South Korea

RECRUITING

Central Study Contacts

Wonsuk Shin

CONTACT

82-31-780-5346wonsug89@chamc.co.kr

Study Design

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

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 6, 2025

Study Start

November 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations

KR(1)