Safety and Pharmacokinetics of UI112 Compared With UIC202611 in Healthy Adults

Inclusion Criteria:

1. Healthy adult volunteers aged 19 years or older and younger than 65 years at screening.
2. Participants with a body weight of 50.0 kg to 100.0 kg (inclusive) and a body mass index (BMI) of 20.0 kg/m² to 29.9 kg/m² (inclusive) at screening.
3. Participants without congenital diseases or chronic diseases requiring treatment and without pathological symptoms or findings based on a medical examination.
4. Participants determined to be suitable for participation in the clinical trial based on clinical laboratory tests, vital signs, physical examinations, and 12-lead electrocardiograms (ECGs) performed at screening.
5. Participants who voluntarily decide to participate after receiving and fully understanding detailed information about the clinical trial, provide written informed consent, and agree to comply with the study requirements throughout the clinical trial.

Exclusion Criteria:

1. Current or past history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, neoplastic, genitourinary, cardiovascular, gastrointestinal, musculoskeletal, or other clinically significant diseases.
2. Pregnant women (positive urine human chorionic gonadotropin [HCG] test) or breastfeeding women.
3. History of hypersensitivity reactions, including anaphylaxis or angioedema, or other clinically significant hypersensitivity to the active ingredient, excipients of the investigational products, or other drugs, including GLP-1 receptor agonists.
4. History of skin diseases (e.g., burns or skin cancer) or skin transplantation that may affect the absorption of the investigational products.
5. History of acute or chronic pancreatitis.
6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
7. Clinically significant abnormalities on a 12-lead ECG at screening, including any of the following:

QTc interval >450 ms in males or >460 ms in females.

PR interval >200 ms.

QRS duration >120 ms. 8. Clinically significant abnormalities in clinical laboratory tests at screening, including any of the following:

AST, ALT, ALP, gamma-GT, or total bilirubin >2 times the upper limit of normal (ULN).

Serum creatinine outside the reference range or estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI equation, <60 mL/min/1.73 m².

Lipase or amylase >2 times the ULN.

HbA1c ≥6.5%. 9. History of drug abuse or a positive urine drug screening test for drugs of abuse.

10. Abnormal vital signs measured in a sitting position after at least 3 minutes of rest at screening, including any of the following:

Systolic blood pressure ≤90 mmHg or ≥150 mmHg.

Diastolic blood pressure ≤60 mmHg or ≥100 mmHg.

Pulse rate ≤40 bpm or ≥100 bpm. 11. Use of drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month before the first administration of the investigational product.

12. Use of any prescription medication or herbal medicine that may affect the characteristics of the investigational products within 2 weeks before the first administration, or use of any over-the-counter medication or health functional food within 10 days before the first administration. However, participation may be permitted at the investigator's discretion if the medication is not expected to affect the pharmacokinetic characteristics of the investigational products.

13. Participation in another clinical trial involving administration of an investigational product within 6 months before the first administration in this study. The day following the last administration in the previous clinical trial is considered Day 1.

14. Donation of whole blood within 2 months, donation of blood components within 1 month, or receipt of a blood transfusion within 1 month before the first administration, or inability to refrain from blood donation from the time of written informed consent until the post-study visit (PSV).

15. Regular alcohol consumption exceeding 21 units per week within 6 months before the first administration (1 unit = 10 g or 12.5 mL of pure alcohol), or inability to abstain from alcohol from the time of written informed consent until the PSV.

16. Smoking more than an average of 10 cigarettes per day within 3 months before the first administration, or inability to abstain from smoking from 24 hours before the first administration until the final blood sampling.

17. Consumption of grapefruit or grapefruit-containing foods within 72 hours before the first administration, or inability to abstain from such foods until the PSV.

18. Consumption of caffeine-containing foods or beverages (e.g., coffee, green tea, black tea, carbonated beverages, coffee-flavored milk, or energy drinks) within 24 hours before the first administration, or inability to abstain from such products until the final blood sampling.

19. Engagement in strenuous exercise exceeding the level of normal daily activities within 72 hours before the first administration, or inability to refrain from such exercise until the PSV.

20. Inability to maintain dietary habits and physical activity levels comparable to normal daily life from the time of written informed consent until the PSV.

21. Following an abnormal diet that may affect the absorption, distribution, metabolism, or excretion of the investigational products, or consuming foods that may affect drug metabolism.

22. Change in body weight of 5% or more within the previous 3 months. 23. Participants who, or whose spouse or partner, plan to become pregnant, or who do not use reliable contraception even without pregnancy plans, from the time of written informed consent until 60 days after the final administration of the investigational product. Reliable contraceptive methods include implants or intrauterine devices, sterilization procedures (e.g., vasectomy or tubal ligation), and barrier methods (e.g., condoms, contraceptive diaphragms, vaginal sponges, or cervical caps used in combination).

24. Presence of tattoos, sunburn, thermal burns, or other skin abnormalities at the administration site, including cuts, bruising, erythema, induration, or tenderness, that may interfere with medical assessments before or after administration of the investigational products.

25. Participants considered unsuitable for participation in the clinical trial by the investigator for any reason other than the inclusion and exclusion criteria specified above.