Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection

Inclusion Criteria:

• Voluntarily sign the informed consent form.

• Age 18-65 years (inclusive), male or female.

• The result of 13C-UBT is positive (≥ 4 Delta Over Baseline), and the infection of H.pylori are confirmed by gastroscopic biopsy histology.

• Subjects agree to refrain from taking any antibiotics or traditional Chinesemedicines with antibacterial effect, bismuth, and antacids (such as proton pumpinhibitor, H2 receptor blocker, P-CAB) other than the study drugs during theScreening Period until the end of the study (Visit 5, i.e., Efficacy EvaluationVisit).

• Subjects and their heterosexual partners must agree to have no pregnancy plan andvoluntarily take effective contraceptive measures during the trial and for at least 6 months after the end of the study medication.

• Willing to follow and able to complete all trial procedures.

Exclusion Criteria:

• Allergy to any of the study drugs (rabeprazole, amoxicillin, clarithromycin, bismuthpotassium citrate), allergic constitution (multiple drug and food allergies); or anycontraindication to the use of rifamycin, nitroimidazoles or study drugs.

• History of H. pylori eradication therapy (including participation in other clinicaltrials for H. pylori eradication).

• Subjects with confirmed tuberculosis (TB) or Mycobacterium avium complex (MAC)infection or a history of TB or MAC infection.

• History of dysphagia or any gastrointestinal disorder affecting drug absorption.

• History of obstruction pyloric; or excessive gastric acid secretion (such asZollinger-Ellison syndrome).

• History of gastric cancer.

• History of neoplasm malignant within 5 years prior to screening, with the exceptionof basal cell carcinoma or carcinoma cervix in situ treated without evidence ofrecurrence.

• History of esophageal or gastric surgery, except for simple repair of the perforatedulcer.

• History of substance abuse or drug use within 5 years prior to screening.

• Alcohol abuse or a history of alcohol abuse within 5 years prior to screening (average weekly consumption of ≥ 14 units of alcohol: 1 unit = 285 mL of beer, or 25mL of spirits, or 100 mL of wine/Chinese rice wine/rice wine);

• Presence of active gastric and/or duodenal ulcer.

• Anticoagulant therapy or long-term treatment with nonsteroidal anti-inflammatorydrugs.

• Treatment with any other investigational new drugs within 4 weeks prior to theScreening Period.

• Any prohibited medications or non-drug therapies as specified in the protocol (seeSection 10.3).

• White blood cell count or neutrophil count below the lower limit of normal range.

• Anemia (hemoglobin < 90 g/L).

• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin,or serum creatinine above the upper limit of normal range.

• Test positive for hepatitis B surface antigen, hepatitis C antibody, AIDS antibody,or microspironema pallidum antibody.

• Abnormal ECG with clinical significance.

• Female subjects who are pregnant, lactating, or have a positive urine pregnancyresult during the Screening Period.

• Inability to communicate with the Investigator and to comply with the studyrequirements.

• Other conditions considered inappropriate to participate in this study by theInvestigator, e.g., the subject has a history of severe central nervous system,cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological,endocrine, or hematological diseases, or has clinical manifestations of thesediseases.