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

NCT06076694 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TNP-2198-06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Group A

EXPERIMENTAL

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; Drug: Rabeprazole Sodium; Drug: Amoxicillin

Group B

EXPERIMENTAL

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

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

Group C

EXPERIMENTAL

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

Drug: TNP-2198; Drug: Rabeprazole Sodium

Group D

EXPERIMENTAL

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

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

Control group

ACTIVE COMPARATOR

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

Drug: Rabeprazole Sodium; Drug: Amoxicillin

Interventions

TNP-2198 DRUG

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

Also known as: Rifasutenizol

Group A; Group B; Group C; Group D

Rabeprazole Sodium DRUG

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

Control group; Group A; Group B; Group C; Group D

Amoxicillin DRUG

Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days

Control group; Group A; Group B; Group D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• TenNor Therapeutics (Suzhou) Limited: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Related Publications (1)

• Li X, Liu Y, Wang M, Gao L, Liu J, Zhang H, Wu M, Chen H, Lou J, Wang J, Chen J, Geng G, Ma Z, Ding Y. Safety, pharmacokinetics, and efficacy of rifasutenizol, a novel dual-targeted antibacterial agent in healthy participants and patients in China with Helicobacter pylori infection: four randomised clinical trials. Lancet Infect Dis. 2024 Jun;24(6):650-664. doi: 10.1016/S1473-3099(24)00003-3. Epub 2024 Feb 12.

  PMID: 38359854 DERIVED

MeSH Terms

Interventions

Rabeprazole; Amoxicillin

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Results Point of Contact

• Title: TenNor
• Organization: Clinical Study Center of the First Hospital of Jilin University

info@tennorx.com

0512-86861979

Study Officials

• TenNor Clinical Trials

  TenNor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 11, 2023
• Study Start: June 26, 2022
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: December 12, 2023
• Results First Posted: December 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)