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

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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: TNP-2198; Drug: Rabeprazole Sodium; Drug: Amoxicillin

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jilin
    • Chang chun, Jilin, China
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: TenNor Therapeutics (Suzhou) Limited
• Investigators: Study Director: TenNor Clinical Trials, TenNor

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2022
• Primary Completion (Actual): September 20, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole; Amoxicillin
• Other Study ID Numbers: TNP-2198-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No