ClinicalTrials.gg
RecruitingNCT06736587Updated Jun 8, 2026

Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers

A Phase 1 interventional study of DWP212525 XXmg and DWP212525 placebo in Autoimmune Diseases, sponsored by Daewoong Pharmaceutical Co. LTD.. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Autoimmune Diseases

Browse trials for

03

In context

Autoimmune Diseases

802 studies on the registry are indexed under Autoimmune Diseases; 271 are open to participants now.

This study's planned enrollment of 84 is above the median of 40 across 541 interventional studies indexed under Autoimmune Diseases.

Browse Autoimmune Diseases studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 200 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adult volunteers aged 19 to 55 years
  2. Those with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a (BMI) of ≥ 18.0 kg/m2 to ≤ 30.0 kg/m2
  3. Received a sufficient explanation on this study
  4. Eligible as subjects in the study

Exclusion criteria

Exclusion Criteria:

  1. History of diseases such as disease of hepatobiliary
  2. Following conditions applicable to clinically significant acute or chronic infections or the past history confirmed via an interview
  3. Hemato-oncologic diseases, including malignant tumor diagnosis
  4. Past history of tuberculosis infection or confirmed tuberculosis in the IGRA test and chest X-ray test
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Cohort1

    Drug: DWP212525 XXmg · Drug: DWP212525 placebo

  • Experimental
    Cohort2

    Drug: DWP212525 XXmg · Drug: DWP212525 placebo

  • Experimental
    Cohort3

    Drug: DWP212525 XXmg · Drug: DWP212525 placebo

  • Experimental
    Cohort4

    Drug: DWP212525 XXmg · Drug: DWP212525 placebo

  • Experimental
    Cohort5

    Drug: DWP212525 XXmg · Drug: DWP212525 placebo

  • Experimental
    Cohort6

    Drug: DWP212525 XXmg · Drug: DWP212525 placebo

  • Experimental
    Cohort7

    Drug: DWP212525 XXmg · Drug: DWP212525 placebo

  • Experimental
    Cohort8

    Drug: DWP212525 XXmg · Drug: DWP212525 placebo

  • Experimental
    Cohort9

    Drug: DWP212525 XXmg · Drug: DWP212525 placebo

  • Experimental
    Cohort10

    Drug: DWP212525 XXmg · Drug: DWP212525 placebo

  • Experimental
    Cohort 11

    Drug: DWP212525 XXmg · Drug: DWP212525 placebo

Interventions

  • DrugDWP212525 XXmg

    DWP212525 XXmg

  • DrugDWP212525 placebo

    DWP212525 placebo

06

What researchers measure

Primary outcomes

  1. PK profiles of DWP212525

    Area under the plasma drug concentration-time curve from 0 to last

    Time frame: Day 1

  2. PK profiles of DWP212525

    The maximum or peak concentration between zero and dosing interval

    Time frame: Day 1

  3. PK profiles of DWP212525

    Time of maximum concentration

    Time frame: Day 1

  4. Safety profiles

    AE, SAE, etc.

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Dec 2026, 24 months after the start.

Of 68 industry-sponsored phase 1 interventional studies under Autoimmune Diseases, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 32. This study's planned 24 months is above that.

Counting every sponsor, half of 94 studies reached it within 23 months; a quarter within 9 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2024
First posted
Dec 16, 2024
StartActual
Dec 10, 2024
Primary completionEst.
Dec 30, 2026
CompletionEst.
Mar 30, 2027
Last update
Jun 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06736587
Responsible party
Sponsor
First posted
Dec 16, 2024
Start date
Dec 10, 2024
Primary completion
Dec 30, 2026 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Jun 8, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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