Clinical trial NCT06076681: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Helicobacter Pylori Infection
Lead sponsor: TenNor Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The Eradication Rate of Helicobacter Pylori Infection
timeFrame: Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50)
Secondary outcomes:
Other outcomes:
Locations:
city: Chang chun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: TenNor
name: TenNor Clinical Trials
role: STUDY_DIRECTOR
References: