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

NCT06076681 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TNP-2198-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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.

  Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50)

Study Arms (4)

Group A

EXPERIMENTAL

TNP2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID

Drug: TNP-2198; Drug: Rabeprazole Sodium

Group B

EXPERIMENTAL

TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID

Drug: TNP-2198; Drug: Rabeprazole Sodium

Group C

EXPERIMENTAL

TNP2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID

Drug: TNP-2198; Drug: Rabeprazole Sodium

Group D

EXPERIMENTAL

TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID

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

Interventions

TNP-2198 DRUG

On Days 1 to 14, all subjects in each group received TNP-2198 capsule within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.

Also known as: Rifasutenizol

Group A; Group B; Group C; Group D

Rabeprazole Sodium DRUG

On Days 1 to 14, all subjects in each group received rabeprazole within 30 minutes before breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes before breakfast.

Group A; Group B; Group C; Group D

Amoxicillin DRUG

On Days 1 to 14, all subjects in each group received Amoxicillin capsule within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast.

Group D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

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 Medical Information
• Organization: TenNor Therapeutics (Suzhou) Limited.

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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 11, 2023
• Study Start: September 27, 2021
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: November 22, 2023
• Results First Posted: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)