Obesity & Overweight, Type 2 Diabetes
Conditions
Brief summary
Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
Interventions
DRUGDWRX5003
Microneedle patch containing Semaglutide
DRUGDWC202502
Semagluide
DRUGDWC202503
Semaglutide
OTHERDWRX5003P
placebo microneedle patch
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This study employs a partial double-blind design.
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC 0-t | Pre-dose (0 hour) up to 672 hours post-dose |
| Cmax | Pre-dose (0 hour) up to 672 hours post-dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC 0-8h, AUC 0-168h, AUCinf | Pre-dose (0 hour) up to 672 hours post-dose | — |
| CL/F, Vd/F | Pre-dose (0 hour) up to 672 hours post-dose | Clearance, Volume of distribution |
| Tmax, t½ | Pre-dose (0 hour) up to 672 hours post-dose | Tmax (time to reach maximum plasma concentration), t½ (elimination half-life) |
| Frel | Pre-dose (0 hour) up to 672 hours post-dose | Relative bioavailability compared to the active control |
Countries
South Korea
Contacts
CONTACTYeaRa Kwak
Outcome results
None listed