RecruitingPhase 1NCT06736587

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Tiral in Healthy Male 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 Male Volunteers


Sponsor

Daewoong Pharmaceutical Co. LTD.

Enrollment

76 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The safety and tolerability of single and multiple administration of DWP212525


Eligibility

Sex: MALEMin Age: 19 YearsMax Age: 55 Years

Inclusion Criteria4

  • Healthy adult male volunteers aged 19 to 55 years, Caucasian
  • 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 Criteria4

  • 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

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Interventions

DRUGDWP212525 10mg

DWP212525 10mg

DRUGDWP212525 30mg

DWP212525 30mg

DRUGDWP212525 50mg

DWP212525 50mg

DRUGDWP212525 100mg

DWP212525 100mg

DRUGDWP212525 200mg

DWP212525 200mg

DRUGDWP212525 400mg

DWP212525 400mg

DRUGDWP212525 placebo

DWP212525 placebo


Locations(1)

Seoul National University Hospital

Seoul, South Korea

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NCT06736587


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