HealthyPhase 1NCT06616883
Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers
A Phase 1 study testing DA-5221_01 and DA-5221_01-R1 + DA-5221_01-R2 in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DA-5221_01 and DA-5221_01-R1 + DA-5221_01-R2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2024to 18 Nov 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- BMI between 18 and 30 kg/m2
- Body weight: Male≥50kg, Female≥45kg
- Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study
Who cannot join
- Subjects with clinically significant medical history
- Subjects with history of drug abuse or addicted
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bumin Hospital
Seoul, South Korea, 07590
TaeGon Hong, Ph.D, tghong@bumin.co.kr
About this study
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Study to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Single Administration of DA-5221_01 and Concomitant Administration of DA-5221_01-R1 and DA-5221_01-R2 Under Fasting Conditions in Healthy Adult Volunteers
Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers
- Conditions
- Healthy
- Being tested
- DA-5221_01, DA-5221_01-R1 + DA-5221_01-R2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5221_01Drug
single dose administration (DA-5221_01 one tablet once a day)
DA-5221_01-R1 + DA-5221_01-R2Drug
single dose administration (DA-5221_01-R1 one tablet once a day + DA-5221_01-R2 one tablet once a day)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Sequence A | Experimental | Not described Receives: Drug: DA-5221_01; Drug: DA-5221_01-R1 + DA-5221_01-R2 |
| Experimental: Sequence B | Experimental | Not described Receives: Drug: DA-5221_01; Drug: DA-5221_01-R1 + DA-5221_01-R2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
area under the curve
Measured: pre-dose~72 hours post-dose
Cmax
maximum plasma concentration
Measured: pre-dose~72 hours post-do
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start30 Sep 2024 (estimated)
- Primary completion14 Nov 2024 (estimated)
- Study completion18 Nov 2024 (estimated)
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
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
- NCT06616883
- Sponsor's protocol ID
- DA5221_01_BE_I
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 27 Sep 2024
- 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Study to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Single Administration of DA-5221_01 and Concomitant Administration of DA-5221_01-R1 and DA-5221_01-R2 Under Fasting Conditions in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06616883
- Acronym / sponsor ID
- DA5221_01_BE_I
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 14 Nov 2024 (estimated)
- Study completion
- 18 Nov 2024 (estimated)
- First posted
- 27 Sep 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.
Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Sequence A | Experimental | Drug: DA-5221_01, Drug: DA-5221_01-R1 + DA-5221_01-R2 |
| Experimental: Sequence B | Experimental | Drug: DA-5221_01, Drug: DA-5221_01-R1 + DA-5221_01-R2 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- BMI between 18 and 30 kg/m2
- Body weight: Male≥50kg, Female≥45kg
- Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study
Key exclusion criteria (2 listed)
- Subjects with clinically significant medical history
- Subjects with history of drug abuse or addicted
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-5221_01single dose administration (DA-5221_01 one tablet once a day) | Drug | Experimental: Sequence A, Experimental: Sequence B |
| DA-5221_01-R1 + DA-5221_01-R2single dose administration (DA-5221_01-R1 one tablet once a day + DA-5221_01-R2 one tablet once a day) | Drug | Experimental: Sequence A, Experimental: Sequence B |
Primary outcome
AUCt
Time frame: pre-dose~72 hours post-dose
area under the curve
Cmax
Time frame: pre-dose~72 hours post-do
maximum plasma concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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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.
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-5221_01 and DA-5221_01-R1 + DA-5221_01-R2 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung (+82-02-920-8369, jhsung@donga.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt (time frame: pre-dose~72 hours post-dose). 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 27 Sep 2024.