Helicobacter Pylori InfectionPhase 1/2NCT06076681
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
A Phase 1/2 study testing TNP-2198, Rabeprazole Sodium and Amoxicillin in people with Helicobacter Pylori Infection, run by TenNor Therapeutics (Suzhou) Limited at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- TNP-2198, Rabeprazole Sodium and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2021to 6 Jan 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- TNP-2198, Rabeprazole Sodium, Amoxicillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNP-2198Drug
Also called Rifasutenizol
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.
Rabeprazole SodiumDrug
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.
AmoxicillinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | TNP2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID Receives: Drug: TNP-2198; Drug: Rabeprazole Sodium |
| Group B | Experimental | TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID Receives: Drug: TNP-2198; Drug: Rabeprazole Sodium |
| Group C | Experimental | TNP2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID Receives: Drug: TNP-2198; Drug: Rabeprazole Sodium |
| Group D | Experimental | TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID Receives: Drug: TNP-2198; Drug: Rabeprazole Sodium; Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Eradication Rate of Helicobacter Pylori Infection
Eradication rate of H. pylori is defined as negative urea breath test result.
Measured: Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start27 Sep 2021
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TenNor Therapeutics (Suzhou) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TenNor Clinical Trials, Study director, TenNor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076681
- Sponsor's protocol ID
- TNP-2198-04
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2023
- Last updated
- 22 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Liu Y, Wang M, Gao L, Liu J, Zhang H, Wu M, Chen H, Lou J, Wang J, Chen J, Geng G, Ma Z, Ding Y. Safety, pharmacokinetics, and efficacy of rifasutenizol, a novel dual-targeted antibacterial agent in healthy participants and patients in China with Helicobacter pylori infection: four randomised clinical trials. Lancet Infect Dis. 2024 Jun;24(6):650-664. doi: 10.1016/S1473-3099(24)00003-3. Epub 2024 Feb 12.
PubMed 38359854
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06076681
- Acronym / sponsor ID
- TNP-2198-04
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TenNor Therapeutics (Suzhou) LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Posted 22 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: TNP-2198, Drug: Rabeprazole SodiumTNP2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID |
| Group B | Experimental | Drug: TNP-2198, Drug: Rabeprazole SodiumTNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID |
| Group C | Experimental | Drug: TNP-2198, Drug: Rabeprazole SodiumTNP2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID |
| Group D | Experimental | Drug: TNP-2198, Drug: Rabeprazole Sodium, Drug: AmoxicillinTNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNP-2198Also: RifasutenizolOn 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. | Drug | Group A, Group B, Group C, Group D |
| Rabeprazole SodiumOn 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 | Group A, Group B, Group C, Group D |
| AmoxicillinOn 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. | Drug | Group D |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38359854Li X, Liu Y, Wang M, Gao L, Liu J, Zhang H, Wu M, Chen H, Lou J, Wang J, Chen J, Geng G, Ma Z, Ding Y. Safety, pharmacokinetics, and efficacy of rifasutenizol, a novel dual-targeted antibacterial agent in healthy participants and patients in China with Helicobacter pylori infection: four randomised clinical trials. Lancet Infect Dis. 2024 Jun;24(6):650-664. doi: 10.1016/S1473-3099(24)00003-3. Epub 2024 Feb 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TenNor Clinical Trials study director
TenNor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TNP-2198, Rabeprazole Sodium and Amoxicillin in people with Helicobacter Pylori Infection, run by TenNor Therapeutics (Suzhou) Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Eradication Rate of Helicobacter Pylori Infection (time frame: Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06076681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.