Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DWP212525 XXmg, DWP212525 placebo.
- Who it may be relevant to
- Registry conditions: Autoimmune Diseases. Basic parameters: 19 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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 volunteers.
Interventions
- Drug DWP212525 XXmg
DWP212525 XXmg - Drug DWP212525 placebo
DWP212525 placebo
Primary outcome measures
- PK profiles of DWP212525 [Time frame: Day 1]
- PK profiles of DWP212525 [Time frame: Day 1]
- PK profiles of DWP212525 [Time frame: Day 1]
- Safety profiles [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT06736587 · DW_DWP212525101