DRUG
DWRX5003
Microneedle patch containing Semaglutide
Status
Recruiting
Phase
Phase 1
Enrollment
72
Locations
1
Results
Not posted
Publications
0
Study summary
Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
Interventions
DRUG
Microneedle patch containing Semaglutide
DRUG
Semagluide
DRUG
Semaglutide
OTHER
placebo microneedle patch
Timeline
First posted
Apr 20, 2026
Study start
May 6, 2026
Primary completion
Oct 27, 2026
Study completion
Nov 17, 2026
Results posted
Not reported
Registry updated
Jul 16, 2026
Outcomes
AUC 0-t
Time frame · Pre-dose (0 hour) up to 672 hours post-dose
Cmax
Time frame · Pre-dose (0 hour) up to 672 hours post-dose
AUC 0-8h, AUC 0-168h, AUCinf
Time frame · Pre-dose (0 hour) up to 672 hours post-dose
CL/F, Vd/F
Time frame · Pre-dose (0 hour) up to 672 hours post-dose
Clearance, Volume of distribution
Tmax, t½
Time frame · Pre-dose (0 hour) up to 672 hours post-dose
Tmax (time to reach maximum plasma concentration), t½ (elimination half-life)
Frel
Time frame · Pre-dose (0 hour) up to 672 hours post-dose
Relative bioavailability compared to the active control
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.
Study locations
South Korea. Showing up to 24 locations stored in the fast local snapshot.
Seoul National University Hospital
Seoul, South Korea
Publications
No PMID-linked publications were present in this registry snapshot.
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