the Safety, Tolerability and Pharmacokinetics of Mulberry Twig Alkaloids in Human

Inclusion Criteria:

1. Male or female, aged 18-55 years (both inclusive) at the time of signing informedconsent.

2. Healthy volunteers,Body mass index between 18.5 and 24 kilogram per meter square (kg/m/m²) 18.5 inclusive). For obese or overweight participants, BMI must be atleast 24 kg/m², with a requirement for some participants to have a BMI of 28 kg/m²or higher.

3. Subjects should have no history or current evidence of heart, liver, kidney,gastrointestinal, neurological, respiratory, psychiatric disorders, or metabolicabnormalities that the investigator deems requiring treatment. Vital signs, physicalexamination, laboratory tests, electrocardiogram (ECG), chest X-ray, abdominalultrasound results should either be normal or show abnormalities that are deemedclinically insignificant by the attending physician.

4. Participants must not plan to become pregnant for six months following the last doseof the study drug, agree to use effective contraception to prevent pregnancy orcausing pregnancy in their partner, and have no intention to donate sperm or eggsduring the study period.

5. Individuals must comprehend the procedures and methods of this clinical trial,voluntarily participate and personally sign the informed consent form, demonstratingwillingness to adhere to the protocol requirements and cooperate in providingbiological samples according to the scheduled plan for testing.

Exclusion Criteria:

1. Secondary obesity, including conditions such as Cushing's syndrome, hypogonadism,growth hormone deficiency, hypothalamic disorders, pseudohypoparathyroidism,insulinoma, and hypothyroidism;

2. Presence of diseases exacerbating gastrointestinal bloating (e.g., Roemheldsyndrome, severe hernias, intestinal obstruction, and peptic ulcers) or chronicgastrointestinal dysfunction with evident digestion and absorption disorders;

3. Diagnosis of diabetes mellitus according to the diagnostic guidelines set forth bythe World Health Organization (WHO);

4. History of atopic allergic diseases or known allergies to the investigationalproduct, its excipients, or similar medications;

5. History of orthostatic hypotension, syncope, transient loss of vision, or severeepisodes of hypoglycemia;

6. Positive test results for Hepatitis B surface antigen (HBsAg), Hepatitis C virusantibody (anti-HCV), Human Immunodeficiency Virus antibody (anti-HIV), or Treponemapallidum antibody (TP-Ab).

7. Participants with a history of drug abuse within 12 months prior to screening orthose with positive urine tests for prohibited drugs;

8. Individuals with a history of alcohol abuse or frequent consumption (more than 14units of alcohol per week, with 1 unit approximately equivalent to 360ml of beer, 45ml of 40% alcohol content spirits, or 150ml of wine) within 6 months prior toscreening, or those with a positive breathalyzer test at screening/baseline, orunwillingness to abstain from alcohol during the study;

9. Those who smoked an average of more than 5 cigarettes per day within 3 months priorto screening, or unwilling to quit smoking during the study;

10. Individuals who donated blood (including apheresis) or experienced significant bloodloss exceeding 400ml within 3 months prior to screening, received a bloodtransfusion or used blood products;

11. Participants who have taken part in any clinical trial within 3 months prior toscreening, or plan to participate in another trial during or within 1 month afterthis study;

12. Individuals with a clinically significant surgical history as judged by theinvestigator within the screening period, or planning elective surgery between thedosing period and up to 1 month post-dosing;

13. Those who used any prescription drugs, traditional Chinese medicine, or herbalremedies within 4 weeks prior to dosing, or within 5 half-lives of any prescribedmedication (whichever is longer), and/or consumed over-the-counter drugs, healthsupplements (excluding routine vitamin supplementation) within 2 weeks prior todosing; those vaccinated within 4 weeks before dosing;

14. Participants who consumed excessive amounts of tea, coffee, or caffeine-containingbeverages (≥8 cups, where 1 cup = 250ml) within 2 weeks prior to dosing, or whorefuse to abstain from grapefruit juice or any food and drink containing alcohol andxanthines (including chocolate, tea, coffee, cola, etc.) for 48 hours before dosingand throughout the study;

15. Individuals who have been on a diet or undergone weight loss treatments within amonth prior to dosing, or have made significant changes to their lifestyle habits (diet, exercise, etc.);

16. Pregnant or breastfeeding women, or those of childbearing potential who hadunprotected sexual intercourse within 30 days prior to screening;

17. Participants with difficult venous access, poor peripheral venous condition, orunable to tolerate multiple blood draws, or have any contraindications to bloodsampling;

18. Unwillingness or inability to follow lifestyle guidance as described in the studyprotocol;

19. Participants who are directly involved in this trial or are relatives (spouse,parents/legal guardians, siblings, or children) of personnel from the researchcenter or the sponsor;

20. As judged by the investigator, individuals with conditions that may affect drugabsorption, distribution, metabolism, excretion, or safety assessment, or that mayreduce compliance, or those whom the investigator deems to pose a safety risk byparticipating in the study, as well as any other circumstances rendering themunsuitable for this trial.