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

Subjects will be randomly assigned to test group or control group at a 1:1 ratio stratified by study site, and will receive Rifasutenizol capsules, rabeprazole sodium enteric-coated tablets, amoxicillin capsules combined with clarithromycin placebo tablets and bismuth potassium citrate placebo capsules (test group), or bismuth-containing quadruple regimen of amoxicillin capsules, clarithromycin tablets, rabeprazole sodium enteric-coated tablets and bismuth potassium citrate capsules combined with Rifasutenizol placebo capsules (control group) for 14 consecutive days.

carbon-13 (13C) UBT will be performed 4-6 weeks after the last dose to evaluate the eradication effect of H. pylori.

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 Chinese medicines with antibacterial effect, bismuth, and antacids (such as proton pump inhibitor, H2 receptor blocker, P-CAB) other than the study drugs during the Screening Period until the end of the study (Visit 5, i.e., Efficacy Evaluation Visit).
• Subjects and their heterosexual partners must agree to have no pregnancy plan and voluntarily 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, bismuth potassium citrate), allergic constitution (multiple drug and food allergies); or any contraindication to the use of rifamycin, nitroimidazoles or study drugs.
• History of H. pylori eradication therapy (including participation in other clinical trials 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 as Zollinger-Ellison syndrome).
• History of gastric cancer.
• History of neoplasm malignant within 5 years prior to screening, with the exception of basal cell carcinoma or carcinoma cervix in situ treated without evidence of recurrence.
• History of esophageal or gastric surgery, except for simple repair of the perforated ulcer.
• 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 25 mL 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-inflammatory drugs.
• Treatment with any other investigational new drugs within 4 weeks prior to the Screening Period.
• Any prohibited medications or non-drug therapies as specified in the protocol (see Section 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 pregnancy result during the Screening Period.
• Inability to communicate with the Investigator and to comply with the study requirements.
• Other conditions considered inappropriate to participate in this study by the Investigator, 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 these diseases.