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

November 2, 2023 updated by: TenNor Therapeutics (Suzhou) Limited

A Phase Ⅰb/Ⅱa, Single-center, Randomized, Open-label Study 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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
TNP2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
Drug: TNP-2198
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.
Other Names:
  • Rifasutenizol
Drug: Rabeprazole Sodium
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.
Experimental: Group B
TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
Drug: TNP-2198
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.
Other Names:
  • Rifasutenizol
Drug: Rabeprazole Sodium
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.
Experimental: Group C
TNP2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
Drug: TNP-2198
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.
Other Names:
  • Rifasutenizol
Drug: Rabeprazole Sodium
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.
Experimental: Group D
TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
Drug: TNP-2198
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.
Other Names:
  • Rifasutenizol
Drug: Rabeprazole Sodium
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.
Drug: Amoxicillin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Eradication Rate of Helicobacter Pylori Infection
Time Frame: 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.
Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TenNor Therapeutics (Suzhou) Limited

Investigators

  • Study Director: TenNor Clinical Trials, TenNor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2021

Primary Completion (Actual)

January 6, 2022

Study Completion (Actual)

January 6, 2022

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

October 7, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNP-2198-04

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Helicobacter Pylori Infection

Clinical Trials on TNP-2198

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe