A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects

Inclusion Criteria:

1. Healthy adult males or females aged 18 to 60 years (inclusive).
2. Body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) in therange 19.0-28.0 kg/m2 for the non-obese group and in the range of 28.1 -35.0 kg/ 2 forthe obese group (inclusive, BMI=weight/height2).
3. No plans to have children within the last 6 months, no plans to donate sperm/egg, andwilling to use effective contraception within 6 months after the end of dosing
4. No clinically significant vital signs, physical examination, laboratory tests, or ECGor chest radiograph findings.
5. Subjects understand and comply with the study procedures, voluntarily participate, andsign an Informed Consent Form.

Exclusion Criteria:

1. History or presence of severe systemic diseases such as endocrine, gastrointestinal,cardiovascular, hematological, hepatic, immunological, renal, respiratory,genitourinary or major neurological (including stroke and chronic epilepsy)abnormalities.
2. History of clinically significant ECG abnormalities or family history of long QTsyndrome (grandparents, parents and siblings) Part A: Any of the following was regarded as a criterion for exclusion:
3. Confirmation of QTcF ≥ 450 ms by repeated measurements;
4. Confirmation of QRS duration > 120 ms by repeated measurements;
5. Confirmation of PR interval > 200 ms by repeated measurements;
6. Findings that lead to difficulties in QTc measurement or difficult interpretationof QTc data;
7. History of other risk factors for Torsades de Pointes tachycardia (e.g., heartfailure, hypokalemia, family history of long QT syndrome);
8. Presence of uncorrected hypokalemia or hypomagnesemia. Parts B and C: Any of the following was regarded as a criterion for exclusion:
9. Family history of long QT syndrome (grandparents, parents and siblings);
10. Resting QTcF ≥ 450 ms (males) or ≥ 460 ms (females) during the screening orbaseline period.
11. Subjects with a known or suspected history of allergy to the test drug or its adjuvantcomponents, or a history of clinically significant severe allergy (e.g., food, drug,latex allergy), or a history of atopic allergic disease (asthma, urticaria, eczematousdermatitis)
12. History of dysphagia or any gastrointestinal disorder affecting drug absorption atscreening, including history of frequent nausea or vomiting of any etiology, historyof irregular gastrointestinal motility such as habitual diarrhea, constipation orbowel pre-excitation syndrome, or history of major gastrointestinal surgery (e.g.,gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastricdivision, or gastric banding)
13. History of pancreatic injury or pancreatitis at screening, or significantly elevatedblood amylase (> 1.5 x ULN)
14. History of urinary tract obstruction or presence of urinary voiding difficulties atscreening.
15. History of cancer (malignancy) at the time of screening.
16. Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis Bsurface antigen (HBsAg), hepatitis C virus (HCV) antibody or syphilis antibody
17. History of significant drug abuse within 12 months prior to screening or positiveurine drug screening
18. Regular alcohol consumption within 3 months prior to screening, consuming more than 3alcoholic drinks per day (one drink is approximately equal to: beer 354 mL/12 ounces,wine 118 mL/4 ounces, or distilled spirits 29.5 mL/1 ounce), or evidence of alcoholabuse and excessive consumption as evidenced by alcohol breath test at screening (subjects who consume 4 alcoholic beverages per day may be enrolled at theinvestigator's (enrollment is at the discretion of the investigator).
19. History of smoking within 3 months prior to screening, or a positive urine nicotinetest at screening, or who cannot give up smoking throughout the study period
20. Excessive daily intake of coffee, tea, cola, energy drinks, or other caffeinatedbeverages within 3 months prior to screening, with excess defined as more than 6servings (one servingis approximately equal to 120 mg of caffeine).
21. Major surgery, or donation or loss of blood over 400 mL within 3 months prior toadministration.
22. Participation in other clinical trials and treatment with investigationalproductinvestigational product within 3 months prior to administration.
23. Taken any prescription, over-the-counter, nutraceutical, herbal or proprietary Chinesemedicine within 4 weeks prior to administration (or less than 5 half-lives of the drugfrom the start of the trial).
24. Women who are pregnant or breastfeeding, or of childbearing potential who are notusing effective non-hormonal contraception (intrauterine device (IUD), barrier methodwith spermicide, or surgical sterilization, etc.) or are unwilling to continue usingthese methods during the trial until 6 months after discontinuation; men ofchildbearing potential who are unwilling to use physical methods of contraceptionduring the trial until 6 months after discontinuation.
25. Systolic blood pressure ≥ 140 mmHg or < 90 mmHg, and/or diastolic blood pressure ≥ 90mmHg or < 50 mmHg at screening or prior to dosing
26. Heart rate < 50 or > 100 beats/min at screening or prior to dosing.
27. The estimated glomerular filtration rate (eGFR) < 90 ml/min/ 1.73m2 at screening basedon the Modification of Diet in Renal Disease Study (MDRD) formula (see Appendix 1 forcalculation formula).
28. At screening, the liver function tests of non-obese group showed any measure ofaspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or total bilirubin> upper limit of normal (ULN); the liver function tests ofobese group showed AST, ALT, or ALP> 1.5 × ULN, or total bilirubin> ULN.
29. Fasting triglycerides > 200 mg/dL (2.27 mmol/L) at screening.
30. Fasting glucose > 5.6 mmol/L in the non-obese group and > 6.1 mmol/L or glycosylatedhemoglobin (HbA1c) ≥ 6.5% in the obese group at screening.
31. Those who could not tolerate blood sample collection.
32. Subjects who are deemed by the investigator to be unsuitable for participation in thestudy.