Testing the safety of DWP212525 in healthy men
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
This study is testing the safety of a new drug called DWP212525 in healthy men to see how well they can tolerate different doses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 19 Years to 55 Years |
| Sex | Male |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06736587 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of the drug DWP212525 through single and multiple doses in healthy adult male volunteers. Participants will receive varying doses of the drug, ranging from 10mg to 200mg, to assess how well it is tolerated. The study is designed as a randomized, double-blind, placebo-controlled trial, ensuring that neither the participants nor the researchers know who receives the active drug versus a placebo. The primary focus is on understanding the drug's safety profile in a controlled environment.
Who should consider this trial
Good fit: Ideal candidates are healthy adult male volunteers aged 19 to 55 years, who are Caucasian and meet specific weight and BMI criteria.
Not a fit: Patients with a history of significant diseases, infections, or certain cancers will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of DWP212525's safety, paving the way for its use in treating autoimmune diseases.
How similar studies have performed: While this approach is common in early-phase trials, the specific drug DWP212525 has not been tested in this manner before.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.