Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty

Inclusion Criteria:

1. Patients scheduled to undergo elective primary unilateral total knee arthroplasty (TKA);

2. Aged 18-74 years (inclusive) on the day of signing the informed consent form,regardless of gender;

3. Willing and able to voluntarily sign the informed consent form and comply with thestudy protocol;

4. Women of childbearing potential or subjects whose partners are women of childbearingpotential must agree to use effective contraception throughout the study period.Acceptable methods include oral, implantable, or injectable hormonal contraceptives;mechanical products (e.g., intrauterine devices, diaphragms, condoms, spermicides);abstinence; or confirmed sterilization (e.g., vasectomy, hysterectomy, bilateralsalpingectomy, or bilateral oophorectomy).

Exclusion Criteria:

1. Pregnant or breastfeeding female subjects;

2. Body weight <40 kg at screening;

3. History of allergy to contrast agents or inability to undergo bilateral lower limbvenography; history of hypersensitivity to the study drug or drugs of the sameclass; known allergy to enoxaparin or any component listed in the enoxaparinprescribing information;

4. High bleeding risk or contraindications to enoxaparin (e.g., known or suspectedheparin-induced thrombocytopenia, severe hematologic disorders, severe coagulationabnormalities);

5. History of deep vein thrombosis (DVT) or DVT confirmed during screening;

6. Clinically significant medical history, including

7. Hemorrhagic stroke or intracranial conditions (e.g., hemorrhage, tumor,arteriovenous malformation, or aneurysm);

8. Recurrent upper gastrointestinal or genital/urinary tract ulcers/bleeding,intraocular bleeding, or clinical bleeding within 6 months prior to screening (as judged by the investigator to increase bleeding risk);

9. Acute hepatitis within 1 year prior to screening or persistent severe liverdisease (e.g., chronic active hepatitis, cirrhosis, or chronic hepaticinsufficiency);

10. Myocardial infarction, acute coronary syndrome, viral myocarditis, pulmonaryembolism, or coronary revascularization within 6 months prior to screening;transient ischemic attack or ischemic stroke;

11. Chronic congestive heart failure with NYHA Class IV cardiac function;

12. Severe arrhythmias requiring Class Ia or III antiarrhythmic drugs; sinus nodedysfunction, Type II Mobitz or third-degree atrioventricular block withoutpacemaker implantation;

13. History of QTc interval prolongation or QTc interval ≥480 ms during screening;

14. Poorly controlled hypertension within 3 months prior to screening (defined asfailure to achieve target blood pressure despite ≥3 antihypertensive medications) orsystolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHgconfirmed during screening;

15. Major surgery or trauma within 3 months prior to screening, particularly involvingthe brain, spine, or eyes;

16. Use of the following treatments:

17. Ongoing or recent (within 7 days pre-surgery) anticoagulant therapy (e.g.,after mechanical heart valve replacement) or plans to continue such therapyduring the study;

18. Oral antiplatelet therapy (e.g., aspirin >165 mg/day, clopidogrel, ticlopidine,dipyridamole) within 7 days pre-surgery or plans to continue during the study;

19. Long-acting NSAIDs within 7 days or 5 half-lives (whichever is longer) prior tosurgery;

20. Thrombolytic therapy for ischemic disease within 6 months prior to screening;

21. Planned or ongoing use of epidural analgesia post-surgery; planned or ongoing use ofintermittent pneumatic compression devices, electrical/mechanical muscle stimulatorspost-surgery; intraoperative complications (e.g., hemorrhage or severe trauma)during spinal/epidural anesthesia;

22. Laboratory abnormalities at screening:

23. Total bilirubin >1.5×ULN, ALT or AST >3×ULN;

24. Serum creatinine >1.5×ULN; chronic kidney disease with eGFR <30 mL/min/1.73 m²;

25. Hemoglobin <100 g/L;

26. Platelet count <100×10⁹/L;

27. APTT, PT, or INR >ULN with clinical significance (investigator judgment);

28. History of malignancy within 5 years prior to screening (excluding basal cellcarcinoma or Stage I squamous cell carcinoma);

29. Positive serum pregnancy test (hCG) during screening;

30. Participation in another drug/device clinical trial within 1 month prior toscreening or within 5 half-lives of the investigational drug (whichever is longer);

31. History of drug abuse or psychiatric disorders;

32. Other conditions deemed unsuitable for study participation by the investigator.