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

Primary Purpose

Helicobacter Pylori Infection

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TNP-2198
TNP-2198 Placebo
Sponsored by
TenNor Therapeutics (Suzhou) Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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: 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.

Sites / Locations

  • The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Multiple Ascending Doses Cohort 1

Multiple Ascending Doses Cohort 2

Multiple Ascending Doses Cohort 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Incidence of Adverse Events(AEs)
The percentage of subjects with at least one AEs.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
September 25, 2023
Last Updated
October 7, 2023
Sponsor
TenNor Therapeutics (Suzhou) Limited
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1. Study Identification

Unique Protocol Identification Number
NCT06081712
Brief Title
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection
Official Title
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Oral Doses of TNP-2198 Capsules in Asymptomatic Subjects With Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TenNor Therapeutics (Suzhou) Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple Ascending Doses Cohort 1
Arm Type
Experimental
Arm Description
TNP-2198 Capsules 200mg, BID, for 14days
Arm Title
Multiple Ascending Doses Cohort 2
Arm Type
Experimental
Arm Description
TNP-2198 Capsules 400mg,BID, for 14days
Arm Title
Multiple Ascending Doses Cohort 3
Arm Type
Experimental
Arm Description
TNP-2198 Capsules 600mg,BID, for 14days
Intervention Type
Drug
Intervention Name(s)
TNP-2198
Other Intervention Name(s)
Rifasutenizol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
TNP-2198 Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events(AEs)
Description
The percentage of subjects with at least one AEs.
Time Frame
up to 17 days
Secondary Outcome Measure Information:
Title
Area Under the Plasma Concentration-Time Curve from the First Dose Extrapolated to Infinity (AUC0-∞)
Description
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
Title
Area Under the Plasma Concentration-Time Curve from the First Dose to the Last Measurable Concentration (AUC 0-last)
Description
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
Title
Maximum Observed Plasma Concentration (Cmax) of TNP-2198
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TenNor Clinical Trials
Organizational Affiliation
TenNor
Official's Role
Study Director
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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