Healthy AdultPhase 1NCT07007520
A Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult Subjects
A Phase 1 study testing DA-5223(Fasting) and DA-5223(Fed) in people with Healthy Adult, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study will evaluate the food effect on the pharmacokinetics of DA-5223 in healthy adult subjects Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- DA-5223(Fasting) and DA-5223(Fed)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2025to Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Global Clinical Trials Center
Seongnam-si, Gyeonggi-do, 13520
About this study
Official title: An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult Subjects
This study will evaluate the food effect on the pharmacokinetics of DA-5223 in healthy adult subjects
- Conditions
- Healthy Adult
- Being tested
- DA-5223(Fasting), DA-5223(Fed)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5223(Fasting)Drug
once a day
DA-5223(Fed)Drug
once a day
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Not described Receives: Drug: DA-5223(Fasting); Drug: DA-5223(Fed) |
| Sequence B | Experimental | Not described Receives: Drug: DA-5223(Fasting); Drug: DA-5223(Fed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC-last
Area under the plasma concentration-time curve up to the last measurable concentration
Measured: 0~12 hours
Cmax
Peak Plasma Concentration
Measured: 0~12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Why it stopped: Discontinuation of Clinical Trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007520
- Sponsor's protocol ID
- DA5223_FE_I
- Status last verified
- Jun 2026
- First submitted
- 28 May 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07007520
- Acronym / sponsor ID
- DA5223_FE_I
- Conditions
- Healthy Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Discontinuation of Clinical Trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the food effect on the pharmacokinetics of DA-5223 in healthy adult subjects
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: DA-5223(Fasting), Drug: DA-5223(Fed) |
| Sequence B | Experimental | Drug: DA-5223(Fasting), Drug: DA-5223(Fed) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-5223(Fasting)once a day | Drug | Sequence A, Sequence B |
| DA-5223(Fed)once a day | Drug | Sequence A, Sequence B |
Primary outcome
AUC-last
Time frame: 0~12 hours
Area under the plasma concentration-time curve up to the last measurable concentration
Cmax
Time frame: 0~12 hours
Peak Plasma Concentration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DA-5223(Fasting) and DA-5223(Fed) in people with Healthy Adult, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC-last (time frame: 0~12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.