Clinical Trials in South Korea / NCT07539415
Recruiting
Phase 1
A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers
NCT07539415 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Obesity & OverweightType 2 Diabetes
Investigational drug(s) / intervention(s)
DWRX5003DWC202502DWC202503DWRX5003P
DWRX5003: Microneedle patch containing Semaglutide
DWC202502: Semagluide
DWC202503: Semaglutide
DWRX5003P: placebo microneedle patch
Study summary
Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
Eligibility
Inclusion Criteria:
1. Healthy adult volunteers aged ≥ 19 and ≤ 65 years at screening
2. Subjects with a body weight ≥ 50.0 kg to ≤ 100.0 kg and a BMI of ≥ 20.0 kg/m2 to ≤ 29.9 kg/m2 at screening
3. Subjects with no congenital disease or chronic disease requiring treatment as well as no pathologic symptoms or findings based on medical examination
4. Subjects who are determined to be eligible for this study based on results of laboratory tests, vital signs, physical examination, 12-lead electrocardiogram (ECG), etc. set and performed according to the nature of the IP at screening
5. Subjects who voluntarily decided to participate in the study and provided written consent to follow subject compliance requirements during the study after receiving a detailed explanation on this study and fully understanding the information
Exclusion Criteria:
1. Subjects with past or current medical history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, digestive, and musculoskeletal diseases:
2. Females who are pregnant (serum-HCG positive) or breast-feeding
3. Subjects with a history of hypersensitivity (e.g., anaphylaxis or angioedema) or clinically significant hypersensitivity to the active ingredient of the IP, pharmaceutical excipients, or other drugs (e.g., GLP-1 receptor agonists)
4. Subjects with a history of skin disease (e.g., burns, skin cancer, etc.) or skin transplant surgery that could affect the absorption of the investigational product
5. Subjects with a history of acute or chronic pancreatitis
6. Subjects with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
7. Subjects who are deemed ineligible for participation in the study by the investigator for reasons other than the above inclusion/exclusion criteria etc.
Primary outcome measure(s)
- AUC 0-t — Pre-dose (0 hour) up to 672 hours post-dose
- Cmax — Pre-dose (0 hour) up to 672 hours post-dose
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07539415 on ClinicalTrials.gov ↗ ← All trials in South Korea