Helicobacter Pylori Infection
Conditions
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.
Interventions
DRUGTNP-2198
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
DRUGRabeprazole Sodium
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
DRUGAmoxicillin
Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days
Sponsors
TenNor Therapeutics (Suzhou) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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; * 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 Rapid Plasma Reagin（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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Eradication Rate of Helicobacter Pylori Infection | 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 | Eradication rate of H. pylori is defined as negative urea breath test result. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days | 20 |
| Group B TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days | 20 |
| Group C TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days | 10 |
| Group D TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days | 10 |
| Control Group Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days | 20 |
| Total | 80 |
Baseline characteristics
| Characteristic | Total | Group B | Group C | Group A | Group D | Control Group |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants | 20 Participants | 10 Participants | 20 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 38.5 years STANDARD_DEVIATION 9.27 | 38.1 years STANDARD_DEVIATION 8.65 | 35.8 years STANDARD_DEVIATION 9.08 | 40.2 years STANDARD_DEVIATION 9.84 | 40.6 years STANDARD_DEVIATION 7.03 | 37.6 years STANDARD_DEVIATION 10.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 80 Participants | 20 Participants | 10 Participants | 20 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 40 Participants | 8 Participants | 6 Participants | 12 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 40 Participants | 12 Participants | 4 Participants | 8 Participants | 3 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 10 | 0 / 10 | 0 / 20 |
| other Total, other adverse events | 16 / 20 | 20 / 20 | 7 / 10 | 8 / 10 | 14 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 10 | 0 / 10 | 0 / 20 |
Outcome results
Primary
The Eradication Rate of Helicobacter Pylori Infection
Eradication rate of H. pylori is defined as negative urea breath test result.
Time frame: 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
Population: Modified Intent-to-Treat Analysis Set (mITT): Refers to all randomized participants who have 14C UBT performed on Day 28 to 34 after the last dose of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | The Eradication Rate of Helicobacter Pylori Infection | 18 Participants |
| Group B | The Eradication Rate of Helicobacter Pylori Infection | 17 Participants |
| Group C | The Eradication Rate of Helicobacter Pylori Infection | 5 Participants |
| Group D | The Eradication Rate of Helicobacter Pylori Infection | 10 Participants |
| Control Group | The Eradication Rate of Helicobacter Pylori Infection | 16 Participants |