a study to investigate the safety, tolerability, and pharmacokinetics of tnp-2198 capsules in asymptomatic participants with helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

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.