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

Phase 1RecruitingNCT06736587

Daewoong Pharmaceutical Co. LTD.76 enrolled

Overview

The safety and tolerability of single and multiple administration of DWP212525

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Autoimmune Diseases

Interventions

DWP212525 10mgDRUG

DWP212525 10mg

DWP212525 30mgDRUG

DWP212525 30mg

DWP212525 50mgDRUG

DWP212525 50mg

DWP212525 100mg

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING