HealthyPhase 1NCT06391827
A Study to Evaluate Safety, Tolerability, and PK of DA-7503 in Healthy Adult and Elderly Participants
A Phase 1 study testing DA-7503 Single dose and DA-7503 Multiple dose in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This is a double-blind, placebo-controlled, randomized, phase 1 study to evaluate safety, tolerability, and pharmacokinetics of orally administered DA-7503 after single and multiple ascending dose regimens in healthy adult and elderly participants Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DA-7503 Single dose and DA-7503 Multiple dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 May 2024to 12 Jan 2026
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers(Age: 19~55 years, 65~85 years)
- Body weight≥50.0kg, 18.0kg/m²≤BMI≤30.0kg/m²
Who cannot join
- Clinically significant Medical History
- Allergy or Drug hypersensitivity
- AST, ALT, Total billurbin > Upper Normal Range*1.5, eGFR<60mL/min/1.73m²
- Positive for serum test results(hepatitis B, hepatitis C, HIV, syphilis test)
- Heavy smoker(more than 10 cigarettes/day)
- Heavy caffeine intake(more than 5 units/day)
- Heavy alcohol intake(more than 210g/week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Orally Administered DA-7503 After Single and Multiple Ascending Dose Regimens in Healthy Adult and Elderly Participants
This is a double-blind, placebo-controlled, randomized, phase 1 study to evaluate safety, tolerability, and pharmacokinetics of orally administered DA-7503 after single and multiple ascending dose regimens in healthy adult and elderly participants
- Conditions
- Healthy
- Being tested
- DA-7503 Single dose, DA-7503 Multiple dose, Placebo Single dose, Placebo Multiple dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-7503 Single doseDrug
Oral administration for once; Dose strength is different for each cohort(Cohort 1, 2, 3, 4, 5 and 6).
DA-7503 Multiple doseDrug
Oral administration once daily for 7 days; Dose strength or target volunteer is different for each cohort(Cohort 1, 2, 3, 4 and 5)
Placebo Single doseDrug
Oral administraion for once.
Placebo Multiple doseDrug
Oral administration once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| [Single dose] DA-7503 | Experimental | 6 subjects in each Cohort(Cohort 1-6) Receives: Drug: DA-7503 Single dose |
| [Single dose] Placebo | Placebo comparator | 2 subjects in each Cohort(Cohort 1-6) Receives: Drug: Placebo Single dose |
| [Multiple dose] DA-7503 | Experimental | 6 subjects in each Cohort(Cohort 1-5) Receives: Drug: DA-7503 Multiple dose |
| [Multiple dose] Placebo | Placebo comparator | 2 subjects in each Cohort(Cohort 1-5) Receives: Drug: Placebo Multiple dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of DA-7503 single dose oral administration
Peak Plasma Concentration of DA-7503 (Cmax)
Measured: 5 days
Pharmacokinetics of DA-7503 single dose oral administration
Area under the plasma concentration versus time curve of DA-7503 (AUClast)
Measured: 5 days
Pharmacokinetics of DA-7503 multiple dose oral administration
Peak Plasma Concentration of DA-7503 (Cmax)
Measured: 11 days
Pharmacokinetics of DA-7503 multiple dose oral administration
Area under the plasma concentration versus time curve of tau (AUCtau)
Measured: 11 days
Pharmacokinetics of DA-7503 multiple dose oral administration
Peak Plasma Concentration of DA-7503 in steady state (Cmax,ss)
Measured: 11 days
Pharmacokinetics of DA-7503 multiple dose oral administration
Area under the plasma concentration versus time curve of tau in steady state (AUCtau,ss)
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start27 May 2024
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 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
- NCT06391827
- Sponsor's protocol ID
- DA7503_AD_Ia
- Status last verified
- May 2026
- First submitted
- 21 Apr 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Orally Administered DA-7503 After Single and Multiple Ascending Dose Regimens in Healthy Adult and Elderly Participants
- ClinicalTrials.gov ID
- NCT06391827
- Acronym / sponsor ID
- DA7503_AD_Ia
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 May 2024 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 30 Apr 2024 (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 is a double-blind, placebo-controlled, randomized, phase 1 study to evaluate safety, tolerability, and pharmacokinetics of orally administered DA-7503 after single and multiple ascending dose regimens in healthy adult and elderly participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| [Single dose] DA-7503 | Experimental | Drug: DA-7503 Single dose6 subjects in each Cohort(Cohort 1-6) |
| [Single dose] Placebo | Placebo comparator | Drug: Placebo Single dose2 subjects in each Cohort(Cohort 1-6) |
| [Multiple dose] DA-7503 | Experimental | Drug: DA-7503 Multiple dose6 subjects in each Cohort(Cohort 1-5) |
| [Multiple dose] Placebo | Placebo comparator | Drug: Placebo Multiple dose2 subjects in each Cohort(Cohort 1-5) |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers(Age: 19~55 years, 65~85 years)
- Body weight≥50.0kg, 18.0kg/m²≤BMI≤30.0kg/m²
Key exclusion criteria (7 listed)
- Clinically significant Medical History
- Allergy or Drug hypersensitivity
- AST, ALT, Total billurbin > Upper Normal Range*1.5, eGFR<60mL/min/1.73m²
- Positive for serum test results(hepatitis B, hepatitis C, HIV, syphilis test)
- Heavy smoker(more than 10 cigarettes/day)
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-7503 Single doseOral administration for once; Dose strength is different for each cohort(Cohort 1, 2, 3, 4, 5 and 6). | Drug | [Single dose] DA-7503 |
| DA-7503 Multiple doseOral administration once daily for 7 days; Dose strength or target volunteer is different for each cohort(Cohort 1, 2, 3, 4 and 5) | Drug | [Multiple dose] DA-7503 |
| Placebo Single doseOral administraion for once. | Drug | [Single dose] Placebo |
| Placebo Multiple doseOral administration once daily for 7 days | Drug | [Multiple dose] Placebo |
Primary outcome
Pharmacokinetics of DA-7503 single dose oral administration
Time frame: 5 days
Peak Plasma Concentration of DA-7503 (Cmax)
Pharmacokinetics of DA-7503 single dose oral administration
Time frame: 5 days
Area under the plasma concentration versus time curve of DA-7503 (AUClast)
Pharmacokinetics of DA-7503 multiple dose oral administration
Time frame: 11 days
Peak Plasma Concentration of DA-7503 (Cmax)
Pharmacokinetics of DA-7503 multiple dose oral administration
Time frame: 11 days
Area under the plasma concentration versus time curve of tau (AUCtau)
Pharmacokinetics of DA-7503 multiple dose oral administration
Time frame: 11 days
Peak Plasma Concentration of DA-7503 in steady state (Cmax,ss)
Pharmacokinetics of DA-7503 multiple dose oral administration
Time frame: 11 days
Area under the plasma concentration versus time curve of tau in steady state (AUCtau,ss)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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-7503 Single dose and DA-7503 Multiple dose in people with Healthy, 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 22 May 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetics of DA-7503 single dose oral administration (time frame: 5 days). The study lists 6 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 22 May 2026.