Clinical trial NCT06081712: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Helicobacter Pylori Infection
Lead sponsor: TenNor Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of Adverse Events(AEs)
timeFrame: up to 17 days
Secondary outcomes:
measure: Area Under the Plasma Concentration-Time Curve from the First Dose Extrapolated to Infinity (AUC0-∞)
timeFrame: Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15
measure: Area Under the Plasma Concentration-Time Curve from the First Dose to the Last Measurable Concentration (AUC 0-last)
timeFrame: Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15
measure: Maximum Observed Plasma Concentration (Cmax) of TNP-2198
timeFrame: Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: TenNor
name: TenNor Clinical Trials
role: STUDY_DIRECTOR
References: