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Recruiting Phase 1 NCT06736587

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

Trial Parameters

Condition Autoimmune Diseases
Sponsor Daewoong Pharmaceutical Co. LTD.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 76
Sex MALE
Min Age 19 Years
Max Age 55 Years
Start Date 2024-12-10
Completion 2026-06-30
Interventions
DWP212525 10mgDWP212525 30mgDWP212525 50mg

Brief Summary

The safety and tolerability of single and multiple administration of DWP212525

Eligibility Criteria

Inclusion Criteria: 1. Healthy adult male volunteers aged 19 to 55 years, Caucasian 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

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