Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy 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 Volunteers
1 other identifier
interventional
84
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
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2027
June 8, 2026
December 1, 2025
2.1 years
December 6, 2024
June 3, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
PK profiles of DWP212525
Area under the plasma drug concentration-time curve from 0 to last
Day 1
PK profiles of DWP212525
The maximum or peak concentration between zero and dosing interval
Day 1
PK profiles of DWP212525
Time of maximum concentration
Day 1
Safety profiles
AE, SAE, etc.
Day 1
Study Arms (11)
Cohort1
EXPERIMENTALCohort2
EXPERIMENTALCohort3
EXPERIMENTALCohort4
EXPERIMENTALCohort5
EXPERIMENTALCohort6
EXPERIMENTALCohort7
EXPERIMENTALCohort8
EXPERIMENTALCohort9
EXPERIMENTALCohort10
EXPERIMENTALCohort 11
EXPERIMENTALInterventions
DWP212525 placebo
DWP212525 XXmg
Eligibility Criteria
You may qualify if:
- Healthy adult volunteers aged 19 to 55 years
- 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)
December 30, 2026
Study Completion (Estimated)
March 30, 2027
Last Updated
June 8, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share