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

The safety and tolerability of single and multiple administration of DWP212525

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Diseases
• Intervention / Treatment: Drug: DWP212525 30mg; Drug: DWP212525 placebo; Drug: DWP212525 50mg; Drug: DWP212525 100mg; Drug: DWP212525 200mg; Drug: DWP212525 400mg; Drug: DWP212525 10mg

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Seunghwan Lee; Phone Number: +220720694; Email: leejh413@snu.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort2; SAD	Drug: DWP212525 30mg; DWP212525 30mg; Drug: DWP212525 placebo; DWP212525 placebo
Experimental: Cohort3; SAD	Drug: DWP212525 placebo; DWP212525 placebo; Drug: DWP212525 50mg; DWP212525 50mg
Experimental: Cohort4; SAD	Drug: DWP212525 placebo; DWP212525 placebo; Drug: DWP212525 100mg; DWP212525 100mg
Experimental: Cohort5; SAD	Drug: DWP212525 placebo; DWP212525 placebo; Drug: DWP212525 200mg; DWP212525 200mg
Experimental: Cohort6; SAD	Drug: DWP212525 placebo; DWP212525 placebo; Drug: DWP212525 400mg; DWP212525 400mg
Experimental: Cohort7; MAD	Drug: DWP212525 30mg; DWP212525 30mg; Drug: DWP212525 placebo; DWP212525 placebo
Experimental: Cohort8; MAD	Drug: DWP212525 placebo; DWP212525 placebo; Drug: DWP212525 50mg; DWP212525 50mg
Experimental: Cohort9; MAD	Drug: DWP212525 placebo; DWP212525 placebo; Drug: DWP212525 100mg; DWP212525 100mg
Experimental: Cohort10; MAD	Drug: DWP212525 placebo; DWP212525 placebo; Drug: DWP212525 200mg; DWP212525 200mg
Experimental: Cohort1; SAD	Drug: DWP212525 placebo; DWP212525 placebo; Drug: DWP212525 10mg; DWP212525 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of DWP212525 and metabolite M16	AUClast, AUCinf	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
Concentration of DWP212525 and metabolite M16	Cmax	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
Concentration of DWP212525 and metabolite M16	Tmax	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
Concentration of DWP212525 and metabolite M16	t1/2	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
Concentration of DWP212525 and metabolite M16	CL/F	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
Concentration of DWP212525 and metabolite M16	Vz/F	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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: DW_DWP212525101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No