Healthy Adult VolunteersPhase 1NCT07691242
Multiple Ascending Dose Study of DW4421
A Phase 1 study testing DW4421S-T0, DW4421S-T2 and DW4421S-T1 in people with Healthy Adult Volunteers, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Multiple Ascending Dose of DW4421, phase I Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- DW4421S-T0, DW4421S-T2 and DW4421S-T1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2026to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
- Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
Who cannot join
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Chungbuk National University Hospital
Cheongju-si, North Chungcheong
Chungbuk National University Hospital, +82-43-269-6771, cbnuhirb@naver.com
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety, the Pharmacokinetics and Pharmacodynamics After Multiple Administration of DW4421 in Healthy Adult Volunteers
Multiple Ascending Dose of DW4421, phase I
- Conditions
- Healthy Adult Volunteers
- Being tested
- DW4421S-T0, DW4421S-T2, DW4421S-T1, DW4421S-T3, DW4421S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW4421S-T0Drug
DW4421 5mg
DW4421S-T2Drug
DW4421 15mg
DW4421S-T1Drug
DW4421 20mg
DW4421S-T3Drug
DW4421 30mg
DW4421SDrug
DW4421 40mg
DW4421-3Drug
Zastaprazan 20mg
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 (DW4421S 5mg) | Experimental | DW4421S-T0, 1 tablet will be orally administered in BID for 7days Receives: Drug: DW4421S-T0 |
| cohort 2 (DW4421S 10mg) | Experimental | DW4421S-T0, 1 tablet will be orally administered in QD for 7days Receives: Drug: DW4421S-T0 |
| cohort 3 (DW4421S 15mg) | Experimental | DW4421S-T2, 1 tablet will be orally administered in QD for 7days Receives: Drug: DW4421S-T2 |
| cohort 4 (DW4421S 20mg) | Experimental | DW4421S-T1, 1 tablet will be orally administered in QD for 7days Receives: Drug: DW4421S-T1 |
| cohort 5 (DW4421S 30mg) | Experimental | DW4421S-T3, 1 tablet will be orally administered in QD for 7days Receives: Drug: DW4421S-T3 |
| cohort 6 (DW4421S 40mg) | Experimental | DW4421S, 1 tablet will be orally administered in QD for 7days Receives: Drug: DW4421S |
| cohort 7 (Zastaprazan 20mg) | Active comparator | DW4421-3, 1 tablet will be orally administered in QD for 7days Receives: Drug: DW4421-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss, Area under the drug concentration-time curve of DW4421 following multiple oral administration
Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration
Measured: Day 7
Cmax of DW4421 following multiple oral administration
Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691242
- Sponsor's protocol ID
- DW4421-106
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on whether to share individual participant data has not yet been made. We plan to evaluate the feasibility of data sharing after the study is completed and the primary results are published
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety, the Pharmacokinetics and Pharmacodynamics After Multiple Administration of DW4421 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07691242
- Acronym / sponsor ID
- DW4421-106
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Jul 2026 (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.
Multiple Ascending Dose of DW4421, phase I
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| cohort 1 (DW4421S 5mg) | Experimental | Drug: DW4421S-T0DW4421S-T0, 1 tablet will be orally administered in BID for 7days |
| cohort 2 (DW4421S 10mg) | Experimental | Drug: DW4421S-T0DW4421S-T0, 1 tablet will be orally administered in QD for 7days |
| cohort 3 (DW4421S 15mg) | Experimental | Drug: DW4421S-T2DW4421S-T2, 1 tablet will be orally administered in QD for 7days |
| cohort 4 (DW4421S 20mg) | Experimental | Drug: DW4421S-T1DW4421S-T1, 1 tablet will be orally administered in QD for 7days |
| cohort 5 (DW4421S 30mg) | Experimental | Drug: DW4421S-T3DW4421S-T3, 1 tablet will be orally administered in QD for 7days |
| cohort 6 (DW4421S 40mg) | Experimental | Drug: DW4421SDW4421S, 1 tablet will be orally administered in QD for 7days |
| cohort 7 (Zastaprazan 20mg) | Active comparator | Drug: DW4421-3DW4421-3, 1 tablet will be orally administered in QD for 7days |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
- Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
Key exclusion criteria (1 listed)
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.
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 |
|---|---|---|
| DW4421S-T0DW4421 5mg | Drug | cohort 1 (DW4421S 5mg), cohort 2 (DW4421S 10mg) |
| DW4421S-T2DW4421 15mg | Drug | cohort 3 (DW4421S 15mg) |
| DW4421S-T1DW4421 20mg | Drug | cohort 4 (DW4421S 20mg) |
| DW4421S-T3DW4421 30mg | Drug | cohort 5 (DW4421S 30mg) |
| DW4421SDW4421 40mg | Drug | cohort 6 (DW4421S 40mg) |
| DW4421-3Zastaprazan 20mg | Drug | cohort 7 (Zastaprazan 20mg) |
Primary outcome
AUCτ,ss, Area under the drug concentration-time curve of DW4421 following multiple oral administration
Time frame: Day 7
Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration
Cmax of DW4421 following multiple oral administration
Time frame: Day 7
Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Undecided. A decision on whether to share individual participant data has not yet been made. We plan to evaluate the feasibility of data sharing after the study is completed and the primary results are published
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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.
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 DW4421S-T0, DW4421S-T2 and DW4421S-T1 in people with Healthy Adult Volunteers, run by Daewon Pharmaceutical 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 1 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: opening soon, as of the sponsor's last update on 8 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCτ,ss, Area under the drug concentration-time curve of DW4421 following multiple oral administration (time frame: Day 7). 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 8 Jul 2026.