NCT06081712已完成1 期
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
TenNor Therapeutics (Suzhou) Limited1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年10月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events(AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Multiple Ascending Doses Cohort 1
Experimental
TNP-2198 Capsules 200mg, BID, for 14days
干预措施: TNP-2198 (Drug)
Multiple Ascending Doses Cohort 1
Experimental
TNP-2198 Capsules 200mg, BID, for 14days
干预措施: TNP-2198 Placebo (Drug)
Multiple Ascending Doses Cohort 2
Experimental
TNP-2198 Capsules 400mg,BID, for 14days
干预措施: TNP-2198 (Drug)
Multiple Ascending Doses Cohort 2
Experimental
TNP-2198 Capsules 400mg,BID, for 14days
干预措施: TNP-2198 Placebo (Drug)
Multiple Ascending Doses Cohort 3
Experimental
TNP-2198 Capsules 600mg,BID, for 14days
干预措施: TNP-2198 (Drug)
Multiple Ascending Doses Cohort 3
Experimental
TNP-2198 Capsules 600mg,BID, for 14days
干预措施: TNP-2198 Placebo (Drug)
结局指标
主要结局
Incidence of Adverse Events(AEs)
时间窗: up to 17 days
The percentage of subjects with at least one AEs.
次要结局
- Area Under the Plasma Concentration-Time Curve from the First Dose to the Last Measurable Concentration (AUC 0-last)(Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15)
- Area Under the Plasma Concentration-Time Curve from the First Dose Extrapolated to Infinity (AUC0-∞)(Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15)
- Maximum Observed Plasma Concentration (Cmax) of TNP-2198(Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15)
研究者
研究点 (1)
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