Helicobacter Pylori InfectionPhase 1NCT06081699
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants
A Phase 1 study testing TNP-2198 in people with Helicobacter Pylori Infection, run by TenNor Therapeutics (Suzhou) Limited at 1 site in China.
Trial summary
This was a single-center, randomized, double-blind, placebo-controlled phase 1 study to evaluate the safety, tolerability, pharmacokinetics of single ascending dose and the food effect on the pharmacokinetics of TNP-2198 capsules after single dose oral administration in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- TNP-2198
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2019to 18 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those signed the informed consent form and fully understood the study contents, process and possible adverse reactions before participation in the study;
- Those are able to complete the study according to the requirements of the study protocol;
- Those (including the partner) are willing to use effective contraceptives from the screening up to 6 months after the last dose of study drug;
- Male and female subjects aged 18 to 55 years (inclusive);
- Male subjects no less than 50 kg and female subjects no less than 45 kg. BMI (Body Mass Index= body weight (kg)/height^2 (m^2)): 18-28kg/m^2 (inclusive);
- Health status: no clinically significant history of heart, liver, kidney, digestive tract, nervous system, respiratory system diseases, mental disorders or metabolic abnormalities;
- Normal results or abnormal results without clinical significance in physical examinations and vital signs;
- Clinical laboratory test results are within normal limits or abnormal but without clinical significance as judged by the investigator.
Who cannot join
- Average daily consumption of more than 5 cigarettes within 3 months before 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;
- Using any prescription drug, over-the-counter drug, any vitamin product, or herbal medicine within 14 days prior to screening;
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- 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;
- Taking other study drugs or participating in other clinical studies within 3 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;
- Unable to tolerate standardized meal (two boiled eggs, one butter bacon toast, one box of fried potato chips, and one cup of whole milk) (only for subjects participating in the food effect study);
- With clinically significant ECG abnormalities;
- Female subjects who are lactating or have positive serum pregnancy result during the screening period, or have positive serum pregnancy result during the study;
- With symptoms or previous history of cardiovascular, digestive, respiratory, urinary, neurological, hematologic, immunological, endocrine system diseases, 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);
- Positive viral hepatitis (including hepatitis B and C), HIV antibody, treponema pallidum antibody;
- Acute illness or concomitant medication from the time of signing informed consent to the time of study medication;
- Intake of chocolate, any caffeine- or xanthine-containing food or drink within 48 hours prior to administration of study drug;
- Intake of any alcohol-containing products within 48 hours prior to administration of study drug;
- Positive urine drug screening or history of drug abuse or drug addiction within the past 5 years;
- Other conditions that, in the opinion of the investigator, make the patient participating in this study inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose of TNP-2198 Capsules in Healthy Participants and the Effect of Food on the Pharmacokinetics of TNP-2198 Capsules in Healthy Participants
This was a single-center, randomized, double-blind, placebo-controlled phase 1 study to evaluate the safety, tolerability, pharmacokinetics of single ascending dose and the food effect on the pharmacokinetics of TNP-2198 capsules after single dose oral administration in healthy subjects.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- TNP-2198, TNP-2198 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNP-2198Drug
Also called Rifasutenizol
Oral
TNP-2198 PlaceboDrug
The placebo for TNP-2198 active drug
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Doses Cohort 1 | Experimental | TNP-2198 Capsules 50mg Receives: Drug: TNP-2198 |
| Single Ascending Doses Cohort 2 | Experimental | TNP-2198 Capsules 100mg Receives: Drug: TNP-2198 |
| Single Ascending Doses Cohort 3 | Experimental | TNP-2198 Capsules 200mg Receives: Drug: TNP-2198 |
| Single Ascending Doses Cohort 4 | Experimental | TNP-2198 Capsules 400mg Receives: Drug: TNP-2198 |
| Single Ascending Doses Cohort 5 | Experimental | TNP-2198 Capsules 600mg Receives: Drug: TNP-2198 |
| Single Ascending Doses Cohort 6 | Experimental | TNP-2198 Capsules 800mg Receives: Drug: TNP-2198 |
| Single Ascending Doses Cohort 7 | Experimental | TNP-2198 Capsules 1000mg Receives: Drug: TNP-2198 |
| Food Effect Cohort 8 | Experimental | TNP-2198 Capsules 200mg Receives: Drug: TNP-2198 |
| Placebo Cohort 9 | Placebo comparator | Placebo Receives: Drug: TNP-2198 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Measured: Day 1 to Day 4
Secondary outcomes (3)
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
Plasma concentrations of TNP-2198 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2198 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.
Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t)
Plasma concentrations of TNP-2198 were measured by a specific and validated assay. Plasma PK parameters of TNP-2198 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.
Maximum Observed Plasma Concentration (Cmax) of TNP-2198
Plasma concentrations of TNP-2198 were measured by a specific and validated assay at specified time points
Measured: Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start9 May 2019
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 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
- NCT06081699
- Sponsor's protocol ID
- TNP-2198-01
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- 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 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose of TNP-2198 Capsules in Healthy Participants and the Effect of Food on the Pharmacokinetics of TNP-2198 Capsules in Healthy Participants
- ClinicalTrials.gov ID
- NCT06081699
- Acronym / sponsor ID
- TNP-2198-01
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- TenNor Therapeutics (Suzhou) LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 May 2019 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a single-center, randomized, double-blind, placebo-controlled phase 1 study to evaluate the safety, tolerability, pharmacokinetics of single ascending dose and the food effect on the pharmacokinetics of TNP-2198 capsules after single dose oral administration in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Doses Cohort 1 | Experimental | Drug: TNP-2198TNP-2198 Capsules 50mg |
| Single Ascending Doses Cohort 2 | Experimental | Drug: TNP-2198TNP-2198 Capsules 100mg |
| Single Ascending Doses Cohort 3 | Experimental | Drug: TNP-2198TNP-2198 Capsules 200mg |
| Single Ascending Doses Cohort 4 | Experimental | Drug: TNP-2198TNP-2198 Capsules 400mg |
| Single Ascending Doses Cohort 5 | Experimental | Drug: TNP-2198TNP-2198 Capsules 600mg |
| Single Ascending Doses Cohort 6 | Experimental | Drug: TNP-2198TNP-2198 Capsules 800mg |
| Single Ascending Doses Cohort 7 | Experimental | Drug: TNP-2198TNP-2198 Capsules 1000mg |
| Food Effect Cohort 8 | Experimental | Drug: TNP-2198TNP-2198 Capsules 200mg |
| Placebo Cohort 9 | Placebo comparator | Drug: TNP-2198 PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Those signed the informed consent form and fully understood the study contents, process and possible adverse reactions before participation in the study;
- Those are able to complete the study according to the requirements of the study protocol;
- Those (including the partner) are willing to use effective contraceptives from the screening up to 6 months after the last dose of study drug;
- Male and female subjects aged 18 to 55 years (inclusive);
- Male subjects no less than 50 kg and female subjects no less than 45 kg. BMI (Body Mass Index= body weight (kg)/height^2 (m^2)): 18-28kg/m^2 (inclusive);
Key exclusion criteria (22 listed)
- Average daily consumption of more than 5 cigarettes within 3 months before 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;
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: RifasutenizolOral | Drug | Food Effect Cohort 8, Single Ascending Doses Cohort 1, Single Ascending Doses Cohort 2, Single Ascending Doses Cohort 3, Single Ascending Doses Cohort 4, Single Ascending Doses Cohort 5, Single Ascending Doses Cohort 6, Single Ascending Doses Cohort 7 |
| TNP-2198 PlaceboThe placebo for TNP-2198 active drug | Drug | Placebo Cohort 9 |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Day 1 to Day 4
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
3 secondary outcomes
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
Time frame: Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.
Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t)
Time frame: Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.
Maximum Observed Plasma Concentration (Cmax) of TNP-2198
Time frame: Hour 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 after administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- 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 study testing TNP-2198 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 8 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 13 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants With Adverse Events (AEs) (time frame: Day 1 to Day 4). 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 NCT06081699, 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 13 Oct 2023.