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

TenNor Therapeutics

Status and phase: Completed; Phase 1

Conditions: Helicobacter Pylori Infection

Treatments: Drug: TNP-2198; Drug: TNP-2198 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06081712

TNP-2198-03

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 3 patient groups

Multiple Ascending Doses Cohort 1

Experimental group

Description:

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

Treatment:

Drug: TNP-2198 Placebo

Drug: TNP-2198

Multiple Ascending Doses Cohort 2

Experimental group

Description:

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

Treatment:

Drug: TNP-2198 Placebo

Drug: TNP-2198

Multiple Ascending Doses Cohort 3

Experimental group

Description:

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

Treatment:

Drug: TNP-2198 Placebo

Drug: TNP-2198