Helicobacter Pylori Infection
Conditions
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.
Interventions
DRUGTNP-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.
DRUGRabeprazole 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.
DRUGAmoxicillin
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.
Sponsors
TenNor Therapeutics (Suzhou) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Eradication Rate of Helicobacter Pylori Infection | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A TNP-2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(200mg) and rabeprazole sodium enteric-coated tablets (20 mg) 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. | 10 |
| Group B TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(400mg) and rabeprazole sodium enteric-coated tablets (20 mg) 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. | 10 |
| Group C TNP-2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
On Days 1 to 14, all subjects received TNP-2198 capsules(600 mg) and rabeprazole sodium enteric-coated tablets (20 mg) 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. | 10 |
| Group D TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
On Days 1 to 14, all subjects received TNP-2198 capsules(400mg), rabeprazole sodium enteric-coated tablets(20mg) and Amoxicillin capsules(1g) 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. | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Group A | Group B | Group C | Group D | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 40 Participants |
| Age, Continuous | 39.8 years STANDARD_DEVIATION 9.09 | 38.3 years STANDARD_DEVIATION 10.31 | 41.4 years STANDARD_DEVIATION 6.36 | 40.6 years STANDARD_DEVIATION 10.73 | 40.0 years STANDARD_DEVIATION 8.99 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 40 Participants |
| Race (NIH/OMB) Black or African American | 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 |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 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 |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 3 Participants | 6 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 7 Participants | 4 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 6 / 10 | 8 / 10 | 5 / 10 | 8 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
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: Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | The Eradication Rate of Helicobacter Pylori Infection | 0 Participants |
| Group B | The Eradication Rate of Helicobacter Pylori Infection | 3 Participants |
| Group C | The Eradication Rate of Helicobacter Pylori Infection | 4 Participants |
| Group D | The Eradication Rate of Helicobacter Pylori Infection | 8 Participants |