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

Phase 1

Recruiting

• Conditions: Autoimmune Diseases
• Interventions: Drug: DWP212525 30mg; Drug: DWP212525 50mg; Drug: DWP212525 100mg; Drug: DWP212525 200mg; Drug: DWP212525 400mg; Drug: DWP212525 10mg; Drug: DWP212525 placebo

• Registration Number: NCT06736587
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

The safety and tolerability of single and multiple administration of DWP212525

Detailed Description

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

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study Start: 2024-12-10
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-15
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-18
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort2	DWP212525 30mg	SAD
Cohort2	DWP212525 placebo	SAD
Cohort3	DWP212525 50mg	SAD
Cohort3	DWP212525 placebo	SAD
Cohort4	DWP212525 100mg	SAD
Cohort4	DWP212525 placebo	SAD
Cohort5	DWP212525 200mg	SAD
Cohort5	DWP212525 placebo	SAD
Cohort6	DWP212525 400mg	SAD
Cohort6	DWP212525 placebo	SAD
Cohort9	DWP212525 100mg	MAD
Cohort7	DWP212525 30mg	MAD
Cohort7	DWP212525 placebo	MAD
Cohort8	DWP212525 50mg	MAD
Cohort9	DWP212525 placebo	MAD
Cohort1	DWP212525 placebo	SAD
Cohort8	DWP212525 placebo	MAD
Cohort1	DWP212525 10mg	SAD
Cohort10	DWP212525 200mg	MAD
Cohort10	DWP212525 placebo	MAD

Primary Outcome Measures

Name	Time	Method
Concentration of DWP212525 and metabolite M16	Day 1 0 hour (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72hours post-dose	Vz/F

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of