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Recruiting

NCT Number: NCT06736587

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

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Key information

Conditions

Autoimmune Diseases Immune System Diseases

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Location status: Recruiting

Location contact

Seunghwan Lee

CONTACT

[email protected]

+220720694

About this study

The safety and tolerability of single and multiple administration of DWP212525 will be evaluated in healthy adult volunteers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

DWP212525 XXmg

Drug

DWP212525 XXmg

DWP212525 placebo

Drug

DWP212525 placebo

Primary outcomes

  1. PK profiles of DWP212525

    Time frame: Day 1

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

  2. PK profiles of DWP212525

    Time frame: Day 1

    The maximum or peak concentration between zero and dosing interval

  3. PK profiles of DWP212525

    Time frame: Day 1

    Time of maximum concentration

  4. Safety profiles

    Time frame: Day 1

    AE, SAE, etc.

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 16, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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