Healthy Adult VolunteerPhase 1NCT07364877
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DW4421 and DW4421S in Healthy Adult Volunteers
A Phase 1 study testing DW4421 and DW4421S in people with Healthy Adult Volunteer, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Safety and pharmacokinetic characteristics evaluation of DW4421 and DW4421S 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 Volunteer
- What is being tested?
- DW4421 and DW4421S
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Dec 2025to 18 May 2026
- 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
- Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive)
Who cannot join
- 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.
About this study
Official title: A Randomized, Open-label, Single-dose, 2-sequence, Two-period, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW4421 and DW4421S in Healthy Adult Volunteers
Safety and pharmacokinetic characteristics evaluation of DW4421 and DW4421S
- Conditions
- Healthy Adult Volunteer
- Being tested
- DW4421, DW4421S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW4421Drug
DW4421 or DW4421S
DW4421SDrug
DW4421 or DW4421S
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | cross-over Receives: Drug: DW4421; Drug: DW4421S |
| Sequence B | Experimental | Cross-over Receives: Drug: DW4421; Drug: DW4421S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: up to 48 hour
AUC0-t
Measured: up to 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start28 Dec 2025
- Primary completion19 Mar 2026 (estimated)
- Study completion18 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteerStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 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
- NCT07364877
- Sponsor's protocol ID
- DW4421-104
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, 2-sequence, Two-period, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW4421 and DW4421S in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07364877
- Acronym / sponsor ID
- DW4421-104
- Conditions
- Healthy Adult Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2025 (actual)
- Primary completion
- 19 Mar 2026 (estimated)
- Study completion
- 18 May 2026 (estimated)
- First posted
- 23 Jan 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.
Safety and pharmacokinetic characteristics evaluation of DW4421 and DW4421S
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: DW4421, Drug: DW4421Scross-over |
| Sequence B | Experimental | Drug: DW4421, Drug: DW4421SCross-over |
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
- Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive)
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| DW4421DW4421 or DW4421S | Drug | Sequence A, Sequence B |
| DW4421SDW4421 or DW4421S | Drug | Sequence A, Sequence B |
Primary outcome
Cmax
Time frame: up to 48 hour
AUC0-t
Time frame: up to 48 hour
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 23 Jan 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.
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 DW4421 and DW4421S in people with Healthy Adult Volunteer, 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: enrolling by invitation, as of the sponsor's last update on 23 Jan 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?
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?
Cmax (time frame: up to 48 hour). 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 23 Jan 2026.