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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

Primary Purpose

Helicobacter Pylori Infection

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TNP-2198
Rabeprazole Sodium
Amoxicillin
Sponsored by
TenNor Therapeutics (Suzhou) Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Group D

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

The eradication rate of Helicobacter pylori infection
Eradication rate of H. pylori is defined as negative urea breath test result.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2023
Last Updated
October 7, 2023
Sponsor
TenNor Therapeutics (Suzhou) Limited
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1. Study Identification

Unique Protocol Identification Number
NCT06076681
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
January 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TenNor Therapeutics (Suzhou) Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
TNP2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
Arm Title
Group B
Arm Type
Experimental
Arm Description
TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
Arm Title
Group C
Arm Type
Experimental
Arm Description
TNP2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
Arm Title
Group D
Arm Type
Experimental
Arm Description
TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
Intervention Type
Drug
Intervention Name(s)
TNP-2198
Other Intervention Name(s)
Rifasutenizol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rabeprazole Sodium
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
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.
Primary Outcome Measure Information:
Title
The eradication rate of Helicobacter pylori infection
Description
Eradication rate of H. pylori is defined as negative urea breath test result.
Time Frame
Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TenNor Clinical Trials
Organizational Affiliation
TenNor
Official's Role
Study Director
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Chang chun
State/Province
Jilin
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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