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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06736587

Enrollment

Registered

2024-12-16

Start date

2024-12-10

Completion date

2027-03-30

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases

Brief summary

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.

Interventions

DRUGDWP212525 XXmg

DWP212525 XXmg

DRUGDWP212525 placebo

DWP212525 placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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 body mass index (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

1. History of diseases such as clinically significant 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

Design outcomes

Primary

Measure	Time frame	Description
PK profiles of DWP212525	Day 1	Area under the plasma drug concentration-time curve from 0 to last
Safety profiles	Day 1	AE, SAE, etc.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026