Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants

Study Overview
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Brief Summary
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This is a single-center, randomized, open-label phase Ic/IIb clinical study to evaluate the efficacy and safety of TNP-2198 capsules, rabeprazole sodium enteric-coated tablets and amoxicillin capsules combined with multiple doses of rabeprazole sodium enteric-coated tablets and amoxicillin capsules compared with multiple doses of rabeprazole sodium enteric-coated tablets and amoxicillin capsules combined with multiple doses in Helicobacter pylori infection-positive population.

Official Title
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Single-center, Randomized, Open-label Phase Ic/IIb Clinical Study to Evaluate the Efficacy and Safety of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Combined With Multiple Doses of Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Compared With Multiple Doses of Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Combined With Multiple Doses in Helicobacter Pylori Infection-positive Population

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: TNP-2198
* Drug: Rabeprazole Sodium
* Drug: Amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signing the informed consent form (ICF); Male and female subjects aged 18 to 65 years (inclusive); Health condition: no clinically significant history of heart, liver, kidney, digestive tract, nervous system, respiratory system diseases, mental disorders or metabolic abnormalities; Normal results or clinically insignificant abnormal results in physical examinations and vital signs; Positive result of 14C urea breath test (UBT); The subject (including the partner) is willing to take effective contraceptive measures voluntarily without pregnancy plan in the next 6 months; Willing to follow and able to complete all trial procedures. Exclusion Criteria: History of Helicobacter Pylori eradication therapy (including participation in other clinical studies of Helicobacter Pylori eradication); Average daily consumption of more than 5 cigarettes within 3 months prior to the start of the study; History of hypersensitivity to study drug or its excipients, or allergic constitution (allergy to multiple drugs and food); History of drug and/or alcohol abuse (mean consumption of ≥ 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 100 mL of wine); Blood donation or massive blood loss (> 450 mL) within 3 months prior to screening; Using any drug that changes liver enzyme activity within 28 days prior to screening; Taking orally any prescription drug, over-the-counter drug, any vitamin product, or herbal medicine within 14 days prior to screening; Taking special diet (including dragon fruit, mango, grapefruit, etc.) or strenuous exercise, or having other factors that affect drug absorption, distribution, metabolism, excretion, etc., within 2 weeks prior to screening; Significant changes in diet or exercise habits recently; Those who have participated in, or are still participating in clinical studies within 1 months before taking the study drug; With difficulty in swallowing or history of any gastrointestinal diseases that affect drug absorption; With any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; With clinically significant ECG abnormalities; Female subjects who are lactating during the screening period or during the study, or have positive serum pregnancy test results; With symptoms or previous history of cardiovascular, digestive, respiratory, urinary, neurological, hematologic, immunological, endocrine system diseases or tumor, or psychiatric diseases; Clinically significant abnormalities in clinical laboratory tests, or other clinically significant findings (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, psychiatric, or cardiovascular disease); Those who have positive tests results of viral hepatitis (including hepatitis B and C), HIV antibody, treponema pallidum antibody (additional Rapid Plasma Reagin（RPR）test is required for those with positive treponema pallidum antibody); Acute illness occurs or concomitant medication is used from the date of signing the informed consent to the date prior to study medication; Consumption of chocolate, any caffeine- or xanthine-containing food or drink within 48 hours prior to taking the study drug; Consumption of any alcoholic product within 48 hours prior to taking the study drug; Those who have positive test result of urine drug screening or history of drug abuse or drug addiction within the past 5 years; Those who have other conditions that, in the opinion of the investigator, make participation in this study inappropriate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days | Drug: TNP-2198<br>* Group A, TNP-2198 capsules 400mg(4 capsules),BID, 14days Group B, TNP-2198 capsules 600mg(6 capsules),BID, 14days Group C , TNP-2198 capsules 600mg(6 capsules),TID, 14days Group D, TNP-2198 capsules 600mg(6 capsules),TID, 7days<br>* Other names: Rifasutenizol;Drug: Rabeprazole Sodium<br>* Group A,Group B,Control group: Rabeprazole sodium enteric-coated tablets 20 mg, BID, 14days Group C :Rabeprazole sodium enteric-coated tablets 20 mg, TID, 14 days Group D : Rabeprazole sodium enteric-coated tablets 20 mg, TID, 7 days<br>Drug: Amoxicillin<br>* Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days<br>|
| Experimental: Group B<br>TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days | Drug: TNP-2198<br>* Group A, TNP-2198 capsules 400mg(4 capsules),BID, 14days Group B, TNP-2198 capsules 600mg(6 capsules),BID, 14days Group C , TNP-2198 capsules 600mg(6 capsules),TID, 14days Group D, TNP-2198 capsules 600mg(6 capsules),TID, 7days<br>* Other names: Rifasutenizol;Drug: Rabeprazole Sodium<br>* Group A,Group B,Control group: Rabeprazole sodium enteric-coated tablets 20 mg, BID, 14days Group C :Rabeprazole sodium enteric-coated tablets 20 mg, TID, 14 days Group D : Rabeprazole sodium enteric-coated tablets 20 mg, TID, 7 days<br>Drug: Amoxicillin<br>* Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days<br>|
| Experimental: Group C<br>TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days | Drug: TNP-2198<br>* Group A, TNP-2198 capsules 400mg(4 capsules),BID, 14days Group B, TNP-2198 capsules 600mg(6 capsules),BID, 14days Group C , TNP-2198 capsules 600mg(6 capsules),TID, 14days Group D, TNP-2198 capsules 600mg(6 capsules),TID, 7days<br>* Other names: Rifasutenizol;Drug: Rabeprazole Sodium<br>* Group A,Group B,Control group: Rabeprazole sodium enteric-coated tablets 20 mg, BID, 14days Group C :Rabeprazole sodium enteric-coated tablets 20 mg, TID, 14 days Group D : Rabeprazole sodium enteric-coated tablets 20 mg, TID, 7 days<br>|
| Experimental: Group D<br>TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days | Drug: TNP-2198<br>* Group A, TNP-2198 capsules 400mg(4 capsules),BID, 14days Group B, TNP-2198 capsules 600mg(6 capsules),BID, 14days Group C , TNP-2198 capsules 600mg(6 capsules),TID, 14days Group D, TNP-2198 capsules 600mg(6 capsules),TID, 7days<br>* Other names: Rifasutenizol;Drug: Rabeprazole Sodium<br>* Group A,Group B,Control group: Rabeprazole sodium enteric-coated tablets 20 mg, BID, 14days Group C :Rabeprazole sodium enteric-coated tablets 20 mg, TID, 14 days Group D : Rabeprazole sodium enteric-coated tablets 20 mg, TID, 7 days<br>Drug: Amoxicillin<br>* Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days<br>|
| Active Comparator: Control group<br>Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g | Drug: Rabeprazole Sodium<br>* Group A,Group B,Control group: Rabeprazole sodium enteric-coated tablets 20 mg, BID, 14days Group C :Rabeprazole sodium enteric-coated tablets 20 mg, TID, 14 days Group D : Rabeprazole sodium enteric-coated tablets 20 mg, TID, 7 days<br>Drug: Amoxicillin<br>* Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Eradication Rate of Helicobacter Pylori Infection | Eradication rate of H. pylori is defined as negative urea breath test result. | Group A, B,C,control group: Urea breath test is assessed Day 44 Day 50 after the first dose; Group D: Urea breath test is assessed Day 37  Day 43 after the first dose |