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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06736587
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