Autoimmune DiseasesPhase 1NCT06736587
Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers
A Phase 1 study testing DWP212525 XXmg in people with Autoimmune Diseases, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The safety and tolerability of single and multiple administration of DWP212525 Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- DWP212525 XXmg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Dec 2024to 30 Mar 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers aged 19 to 55 years
- Those with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 30.0 kg/m2
- Received a sufficient explanation on this study
- Eligible as subjects in the study
Who cannot join
- History of diseases such as clinically significant disease of hepatobiliary
- Following conditions applicable to clinically significant acute or chronic infections or the past history confirmed via an interview
- Hemato-oncologic diseases, including malignant tumor diagnosis
- Past history of tuberculosis infection or confirmed tuberculosis in the IGRA test and chest X-ray test
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, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Seunghwan Lee, +220720694, leejh413@snu.ac
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers
The safety and tolerability of single and multiple administration of DWP212525
Read the detailed description
The safety and tolerability of single and multiple administration of DWP212525 will be evaluated in healthy adult volunteers.
- Conditions
- Autoimmune Diseases
- Being tested
- DWP212525 XXmg, DWP212525 placebo
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP212525 XXmgDrug
DWP212525 XXmg
DWP212525 placeboDrug
DWP212525 placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Experimental | Not described Receives: Drug: DWP212525 XXmg; Drug: DWP212525 placebo |
| Cohort2 | Experimental | Not described Receives: Drug: DWP212525 XXmg; Drug: DWP212525 placebo |
| Cohort3 | Experimental | Not described Receives: Drug: DWP212525 XXmg; Drug: DWP212525 placebo |
| Cohort4 | Experimental | Not described Receives: Drug: DWP212525 XXmg; Drug: DWP212525 placebo |
| Cohort5 | Experimental | Not described Receives: Drug: DWP212525 XXmg; Drug: DWP212525 placebo |
| Cohort6 | Experimental | Not described Receives: Drug: DWP212525 XXmg; Drug: DWP212525 placebo |
| Cohort7 | Experimental | Not described Receives: Drug: DWP212525 XXmg; Drug: DWP212525 placebo |
| Cohort8 | Experimental | Not described Receives: Drug: DWP212525 XXmg; Drug: DWP212525 placebo |
| Cohort9 | Experimental | Not described Receives: Drug: DWP212525 XXmg; Drug: DWP212525 placebo |
| Cohort10 | Experimental | Not described Receives: Drug: DWP212525 XXmg; Drug: DWP212525 placebo |
| Cohort 11 | Experimental | Not described Receives: Drug: DWP212525 XXmg; Drug: DWP212525 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profiles of DWP212525
Area under the plasma drug concentration-time curve from 0 to last
Measured: Day 1
PK profiles of DWP212525
The maximum or peak concentration between zero and dosing interval
Measured: Day 1
PK profiles of DWP212525
Time of maximum concentration
Measured: Day 1
Safety profiles
AE, SAE, etc.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start10 Dec 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736587
- Sponsor's protocol ID
- DW_DWP212525101
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06736587
- Acronym / sponsor ID
- DW_DWP212525101
- Conditions
- Autoimmune Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 16 Dec 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.
The safety and tolerability of single and multiple administration of DWP212525
Detailed description
The safety and tolerability of single and multiple administration of DWP212525 will be evaluated in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Cohort1 | Experimental | Drug: DWP212525 XXmg, Drug: DWP212525 placebo |
| Cohort2 | Experimental | Drug: DWP212525 XXmg, Drug: DWP212525 placebo |
| Cohort3 | Experimental | Drug: DWP212525 XXmg, Drug: DWP212525 placebo |
| Cohort4 | Experimental | Drug: DWP212525 XXmg, Drug: DWP212525 placebo |
| Cohort5 | Experimental | Drug: DWP212525 XXmg, Drug: DWP212525 placebo |
| Cohort6 | Experimental | Drug: DWP212525 XXmg, Drug: DWP212525 placebo |
| Cohort7 | Experimental | Drug: DWP212525 XXmg, Drug: DWP212525 placebo |
| Cohort8 | Experimental | Drug: DWP212525 XXmg, Drug: DWP212525 placebo |
| Cohort9 | Experimental | Drug: DWP212525 XXmg, Drug: DWP212525 placebo |
| Cohort10 | Experimental | Drug: DWP212525 XXmg, Drug: DWP212525 placebo |
| Cohort 11 | Experimental | Drug: DWP212525 XXmg, Drug: DWP212525 placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult volunteers aged 19 to 55 years
- Those with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 30.0 kg/m2
- Received a sufficient explanation on this study
- Eligible as subjects in the study
Key exclusion criteria (4 listed)
- History of diseases such as clinically significant disease of hepatobiliary
- Following conditions applicable to clinically significant acute or chronic infections or the past history confirmed via an interview
- Hemato-oncologic diseases, including malignant tumor diagnosis
- Past history of tuberculosis infection or confirmed tuberculosis in the IGRA test and chest X-ray test
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 |
|---|---|---|
| DWP212525 XXmgDWP212525 XXmg | Drug | Cohort 11, Cohort1, Cohort10, Cohort2, Cohort3, Cohort4, Cohort5, Cohort6, Cohort7, Cohort8, Cohort9 |
| DWP212525 placeboDWP212525 placebo | Drug | Cohort 11, Cohort1, Cohort10, Cohort2, Cohort3, Cohort4, Cohort5, Cohort6, Cohort7, Cohort8, Cohort9 |
Primary outcome
PK profiles of DWP212525
Time frame: Day 1
Area under the plasma drug concentration-time curve from 0 to last
PK profiles of DWP212525
Time frame: Day 1
The maximum or peak concentration between zero and dosing interval
PK profiles of DWP212525
Time frame: Day 1
Time of maximum concentration
Safety profiles
Time frame: Day 1
AE, SAE, etc.
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 Jun 2026.
- Individual participant dataSharing planned: No
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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 DWP212525 XXmg in people with Autoimmune Diseases, run by Daewoong 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 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?
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?
PK profiles of DWP212525 (time frame: Day 1). The study lists 4 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 Jun 2026.