Clinical trial
A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers
Recruiting now · Phase 1 · 1 countries · Registry ID NCT07539415
Recruiting nowPhase 1Interventional
What this study is about
Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age19 Years to 64 Years
SexAll
Healthy volunteersAccepted
ConditionObesity & Overweight, Type 2 Diabetes
Full registry criteria
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.
Treatments and study arms
DWRX5003
Drug
Microneedle patch containing Semaglutide
DWC202502
Drug
Semagluide
DWC202503
Drug
Semaglutide
DWRX5003P
Other
placebo microneedle patch
Primary outcomes
AUC 0-tPre-dose (0 hour) up to 672 hours post-dose
CmaxPre-dose (0 hour) up to 672 hours post-dose
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Seoul National University Hospital🇰🇷 Seoul, South Korea
Seongyeon Hong, Pharm D.Contact