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

TenNor Therapeutics

Status and phase: Completed; Phase 2

Conditions: Helicobacter Pylori Infection

Treatments: Drug: TNP-2198; Drug: Amoxicillin; Drug: Rabeprazole Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT06076694

TNP-2198-06

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 5 patient groups

Group A

Experimental group

Description:

TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days

Treatment:

Drug: Rabeprazole Sodium

Drug: TNP-2198

Drug: Amoxicillin

Group B

Experimental group

Description:

TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days

Treatment:

Drug: Rabeprazole Sodium

Drug: TNP-2198

Drug: Amoxicillin

Group C

Experimental group

Description:

TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days

Treatment:

Drug: Rabeprazole Sodium

Drug: TNP-2198

Group D

Experimental group

Description:

TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days

Treatment:

Drug: Rabeprazole Sodium

Drug: TNP-2198

Drug: Amoxicillin

Control group

Active Comparator group

Description:

Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g

Treatment:

Drug: Rabeprazole Sodium

Drug: Amoxicillin