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CompletedNCT06081712Updated Oct 13, 2023

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection

A Phase 1 interventional study of TNP-2198 and TNP-2198 Placebo in Helicobacter Pylori Infection, sponsored by TenNor Therapeutics (Suzhou) Limited. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-10-13.

Sponsored by TenNor Therapeutics (Suzhou) Limited · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2021, 5 years 2 months ago, and no results have been posted to the registry.
  • Registered 2 years 11 months after the study started (first participant enrolled Oct 2020, registered Sep 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study was a Phase 1, single-center, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and preliminary Helicobacter Pylori eradication efficacy of TNP-2198 capsules.

02

Conditions studied

03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 48 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

TenNor Therapeutics (Suzhou) Limited is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 in the study protocol;
  • Those (including the partner) are willing to use effective contraceptions from the screening up to 6 months after the last dose of study drug;
  • Male and female subjects aged 18-55 years (inclusive);
  • Male subjects no less than 50 kg and female subjects no less than 45 kg. Body mass index (BMI) = body weight (kg)/height2 (m2); BMI: 18-28kg/m2 (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 clinically insignificant abnormal results in physical examinations and vital sign assessment;
  • Positive result of 14C urea breath test (UBT).

Exclusion criteria

Exclusion Criteria:

  • Average daily consumption of more than 5 cigarettes within 3 months before the study;
  • 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);
  • History of Helicobacter Pylori eradication;
  • 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;
  • 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;
  • Administration of any other study drug or participation in any drug clinical study within 3 months before administration of 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 or having positive serum pregnancy test during screening or 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 antigen/antibody, treponema pallidum antibody;
  • Acute illness or concomitant medication from the time of signing the 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 product within 48 hours before 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Multiple Ascending Doses Cohort 1

    TNP-2198 Capsules 200mg, BID, for 14days

    Drug: TNP-2198 · Drug: TNP-2198 Placebo

  • Experimental
    Multiple Ascending Doses Cohort 2

    TNP-2198 Capsules 400mg,BID, for 14days

    Drug: TNP-2198 · Drug: TNP-2198 Placebo

  • Experimental
    Multiple Ascending Doses Cohort 3

    TNP-2198 Capsules 600mg,BID, for 14days

    Drug: TNP-2198 · Drug: TNP-2198 Placebo

Interventions

  • DrugTNP-2198

    TNP-2198 capsules/placebo were administered orally twice daily (BID, at 7:00 ± 1 hour in the morning and 19:00 ± 1 hour in the evening) in the fasted state for consecutive 14 days, and the last dose was taken at 7:00 am (±1 hour) on Day 15 in the fasted state, and breakfast or dinner should not be taken within 30 minutes after each dose.

    Also known as: Rifasutenizol

  • DrugTNP-2198 Placebo

    TNP-2198 capsules/placebo were administered orally twice daily (BID, at 7:00 ± 1 hour in the morning and 19:00 ± 1 hour in the evening) in the fasted state for consecutive 14 days, and the last dose was taken at 7:00 am (±1 hour) on Day 15 in the fasted state, and breakfast or dinner should not be taken within 30 minutes after each dose.

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events(AEs)

    The percentage of subjects with at least one AEs.

    Time frame: up to 17 days

Secondary outcomes

  1. Area Under the Plasma Concentration-Time Curve from the First Dose Extrapolated to Infinity (AUC0-∞)

    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.

    Time frame: Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15

  2. Area Under the Plasma Concentration-Time Curve from the First Dose to the Last Measurable Concentration (AUC 0-last)

    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.

    Time frame: Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15

  3. 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

    Time frame: Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15

07

Study locations

1 site
  • The First Hospital of Jilin University
    Changchun, Jilin, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06081712
Lead sponsor
TenNor Therapeutics (Suzhou) Limited
Responsible party
Sponsor
First posted
Oct 13, 2023
Start date
Oct 20, 2020
Primary completion
Jul 15, 2021
Completion
Jul 15, 2021
Last update
Oct 13, 2023

Study contacts

TenNor Clinical Trials
study director · TenNor

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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