Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
Healthy adult volunteers aged ≥ 19 and ≤ 65 years at screening
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
Subjects with no congenital disease or chronic disease requiring treatment as well as no pathologic symptoms or findings based on medical examination
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
Females who are pregnant (serum-HCG positive) or breast-feeding
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)
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
Subjects with a history of acute or chronic pancreatitis
Sequential
DWRX5003
DrugMicroneedle patch containing Semaglutide
DWC202502
DrugSemagluide
DWC202503
DrugSemaglutide
DWRX5003P
Other interventionplacebo microneedle patch
AUC 0-t
Cmax
AUC 0-8h, AUC 0-168h, AUCinf
CL/F, Vd/F
Clearance, Volume of distribution
Tmax, t½
Tmax (time to reach maximum plasma concentration), t½ (elimination half-life)
Frel
Relative bioavailability compared to the active control
AUEC0-5h, AUEC5-10h, iAUC0-5h, iAUC5-10h
Emax of glucose
AUEC0-168h, AUEC0-672h of glucose
body weight
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