A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules

Phase 1

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: TNP-2198; Drug: Rabeprazole Sodium; Drug: Amoxicillin

• Registration Number: NCT06076681
• Lead Sponsor: TenNor Therapeutics (Suzhou) Limited

Brief Summary

This phase Ⅰb/Ⅱa, single-center, randomized, open-label study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary Helicobacter Pylori eradication efficacy in asymptomatic subjects with Helicobacter Pylori infection after multiple doses of TNP-2198 capsules combined with rabeprazole sodium enteric-coated tablets, or TNP-2198 capsules combined with rabeprazole sodium enteric-coated tablets and amoxicillin capsules.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-27
• Primary Completion: 2022-01-06
• Study Completion: 2022-01-06
• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-10-07
• Study First Posted: 2023-10-11
• Status Verified: 2023-11
• Results First Submitted: 2023-11-02
• Results First Submitted QC: 2023-11-02
• Last Update Submitted: 2023-11-02
• Results First Posted: 2023-11-22
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Signing the informed consent form and full understanding study contents, process and possible adverse reactions before participation in the study;
• Able to complete the study according to the requirements of the study protocol;
• The subject (including the partner) is willing to take effective contraceptive measures voluntarily without pregnancy plan in the next 6 months;
• Male and female subjects aged 18 to 65 years (inclusive);
• Male subjects' body weight ≥ 50 kg, or female subjects' body weight ≥ 45 kg, with body mass index within the range of 18-30 kg/m2 (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).
• Clinical laboratory test results are within normal limits or abnormal but without clinical significance as judged by the investigator.

Exclusion Criteria

• History of Helicobacter Pyloreradication 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 t;
• 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 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group D	Amoxicillin	TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
Group B	TNP-2198	TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
Group C	TNP-2198	TNP2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
Group D	TNP-2198	TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
Group A	TNP-2198	TNP2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
Group A	Rabeprazole Sodium	TNP2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
Group B	Rabeprazole Sodium	TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
Group D	Rabeprazole Sodium	TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
Group C	Rabeprazole Sodium	TNP2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID

Primary Outcome Measures

Name	Time	Method
The Eradication Rate of Helicobacter Pylori Infection	Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50)	Eradication rate of H. pylori is defined as negative urea breath test result.

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Chang chun, Jilin, China