A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Tiral in Healthy Male Volunteers
1 other identifier
interventional
76
1 country
1
Brief Summary
The safety and tolerability of single and multiple administration of DWP212525
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2024
CompletedStudy Start
First participant enrolled
December 10, 2024
CompletedFirst Posted
Study publicly available on registry
December 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 18, 2024
December 1, 2024
1.6 years
December 6, 2024
December 15, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
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
Study Arms (10)
Cohort2
EXPERIMENTALSAD
Cohort3
EXPERIMENTALSAD
Cohort4
EXPERIMENTALSAD
Cohort5
EXPERIMENTALSAD
Cohort6
EXPERIMENTALSAD
Cohort7
EXPERIMENTALMAD
Cohort8
EXPERIMENTALMAD
Cohort9
EXPERIMENTALMAD
Cohort10
EXPERIMENTALMAD
Cohort1
EXPERIMENTALSAD
Interventions
DWP212525 placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2024
First Posted
December 16, 2024
Study Start
December 10, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 18, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share