A Study to Evaluate MWN109 Injection in Healthy Subjects

Inclusion Criteria:

1. Males or females, of any race, aged 18 to 50 years (inclusive) at Screening.

2. [Part A: SAD] BMI of 19.0 to 40.0 kg/m2 (inclusive). [Part B: MAD] BMI of 27.0 to 45.0 kg/m2 (inclusive) with a minimum body weight of 50.0 kg for females and 55.0 kgfor males.

3. History of stable body weight for 3 months (defined as change < 5%).

4. Resting heart rate (supine) ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG atScreening.

5. Females of childbearing potential and males will agree to use contraception asdetailed further in the protocol.

6. Male participants must agree to refrain from sperm donation and females shouldrefrain from ova donation from D-1 until 4 months after the last administration.

7. Able to comprehend and willing to sign an ICF and to abide by all study requirementsand restrictions.

Exclusion Criteria:

1. Significant history or clinical manifestation of any cardiovascular, metabolic,allergic, endocrine, renal, hepatic, gastrointestinal, hematological, pulmonary,respiratory, dermatological, neurological, gynecological, psychiatric, disorders asdetermined by the investigator (or designee).

2. History of pheochromocytoma or has uncontrolled blood pressure, as defined assystolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.

3. History of insulinoma or has an event of blood glucose < 2.8 mmol/L within 1 yearprior to Screening, or with ≥ 3 times of hypoglycemia symptoms within 3 months priorto Screening.

4. History of febrile illness within 7 days prior to the first dose of IP orparticipants with evidence of active infection.

5. Any of the following:

6. QTcF > 450 msec regardless of gender , confirmed by repeat measurement.

7. QRS duration > 110 msec confirmed by repeat measurement.

8. PR interval > 220 msec confirmed by repeat measurement.

9. Findings which would make QTc measurements difficult or QTc datauninterpretable.

10. History of additional risk factors for torsades de pointes (e.g., heartfailure, hypokalemia, family history of long QT syndrome).

11. Known history or family history of thyroid C-cell tumor/carcinoma, multipleendocrine neoplasia syndrome type 2 (MEN2), thyroid dysfunction or thyroid hormoneabnormality.

12. History of diabetes mellitus Type I or II or clinical evidence of diabetes (e.g.,hemoglobin A1c ≥ 6.5%, fasting blood glucose ≥ 126 mg/dL [7.0 mmol/L]) at Screening,non-fasting glucose ≥ 200 mg/dL (11.1 mmol/L) at Screening, or use of anyhypoglycemic drugs during Screening or within 3 months prior to Screening

13. History of acute or chronic pancreatitis, symptomatic gallbladder disease,pancreatic injury and other high-risk factors that may lead to pancreatitis.

14. With any of following laboratory abnormality:

15. Elevation in serum amylase or lipase (> 1.5 × upper limit of normal [ULN]).

16. Have serum AST or ALT > 2 × ULN or total bilirubin >1.5 × ULN.

17. Have serum TG ≥ 5.65 mmol/L (500 mg/dL) at screening

18. Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2.

19. History of clinically significant abnormal gastric emptying (e.g., gastric outletobstruction, gastroparesis), severe chronic gastrointestinal diseases (e.g., havingactive ulcer within 6 months prior to Screening, active gastritis or esophagitis, oruncontrolled gastroesophageal reflux disease, irritable bowel disease or severeinflammatory bowel disease).

20. Long-term use of drugs directly affecting the gastrointestinal motility (includingbut not limited to mosapride, cisapride) or gastrointestinal surgery within 12 weeksprior to Screening and are inappropriate for participation in this clinical study asassessed by the Investigator.

21. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), orhuman immunodeficiency virus (HIV-1 and HIV-2) antibodies and p24 antigen.

22. Any history of severe psychiatric disorder such as major depressive disorder,bipolar disorder, and schizophrenia, or history of suicidal ideation, behavior orattempts or other psychiatric disorder (within 2 years of Screening).

23. Any suicidal ideation as identified by endorsement of (answered yes to) any of theitems numbered 1-5 on the Columbia Suicide Severity Rating Scale (C-SSRS), ifapplicable.

24. History of alcoholism or drug/chemical abuse within 1 year prior to D-1.

25. Alcohol consumption of > 21 units per week for males and > 14 units per week forfemales, on average. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.

26. Positive alcohol breath test result or positive urine drug screen (confirmed byrepeat) during the Screening period.

27. Daily use of more than 10 cigarettes/day (on average), or 2 cigars/day (on average),or equivalent use of any tobacco product within 6 weeks prior to Screening.

28. Females of pregnant or lactating, or those with a positive pregnancy test atScreening.

29. Intolerance to venipuncture for blood sampling or history of fainting at blooddrawing or sight of blood, unless deemed acceptable by the Investigator (ordesignee).

30. History of severe Types I-IV hypersensitivity reactions, anaphylaxis, cytokinerelease syndrome, atopic individuals, or allergic reactions to multiple drugs. Ifthe Investigator is considering enrolling a participant with drug allergies,agreement with the Medical Monitor should be sought.

31. History of or suspected allergy or hypersensitivity to the investigational productor its components

32. Use or intend to use any prescription medications/products other than hormonereplacement therapy, oral, implantable, transdermal, injectable, or intrauterinecontraceptives within 14 days prior to dosing, unless deemed acceptable by theInvestigator (or designee).

33. Use or intend to use slow-release medications/products considered to still be activewithin 14 days prior to D-1, unless deemed acceptable by the Investigator (ordesignee).

34. Use or intend to use any nonprescription medications/products including vitamins,minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days priorto D-1, unless deemed acceptable by the Investigator (or designee).

35. Participants with a history of infectious diseases (which may affect the ability ofthe participant to participate in the study at the discretion of the Investigator),severe trauma, or major surgical operation within 4 weeks prior to Screening.

36. Have been vaccinated within 4 weeks prior to Screening or plan to have vaccinationduring the study.

37. Donation of blood or massive blood loss (> 450 mL) OR receipt of blood productswithin 12 weeks prior to Screening.

38. Participation in a clinical study involving administration of an investigationalagent/device or vaccine (new chemical entity) or having received a biologicalproduct within 12 weeks prior to Screening.

39. Poor peripheral venous access.

40. Are investigative site personnel directly affiliated with this study and theirimmediate families. Immediate family is defined as a spouse, parent, child, orsibling, whether biological or legally adopted.

41. The presence of clinically significant physical examination, vital sign, drug, orECG findings at Screening or baseline or laboratory findings at Screening that, inthe opinion of the Investigator or Medical Monitor, may interfere with any aspect ofstudy conduct or interpretation of results.

42. Any skin condition and/or tattoo that may interfere with the evaluation of safety atthe injection site.

43. Are deemed unsuitable by the Investigator (or designee) for any other reason.