ITMCTR2000003169尚未招募1 期
A clinical study evaluating the safety and tolerability of microRNA2911 plasmids in healthy adults
anjing University0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Basic Science
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •1. Healthy male or female subjects >=18 years old at the date of signing the informed consent;
- •2. Male body weight 50kg, female body weight >=45kg, body mass index (BMI) in the range of 19-28kg / m2 (including 19 and 28) (BMI = weight (kg) / height 2 (M2));
- •3. The results of physical examination, vital signs, blood routine, urine routine, blood biochemistry, blood coagulation, abdominal B-ultrasound, chest X-ray and other examinations in the screening period must be within the normal range consistent with age and gender, or meet the requirements of the program, or be judged as NCS if they are beyond the normal range;
- •4. 12 lead ECG was normal, QTCF was less than 430ms in men and 450 ms in women; QTc interval was corrected by friderica formula (QTCF = QT / (RR ^ 0.33), RR was the standardized heart rate value, which was obtained by dividing 60 by heart rate);
- •5. Pregnancy test is negative in women of childbearing age;
- •6. Agree to abstain or take effective non drug contraceptive measures within at least 3 months from screening to the last study drug administration (female subjects also require to start abstinence or take effective non drug contraceptive measures two weeks before entering the study);
- •7. Subjects who can communicate well with researchers, understand and comply with the requirements of this study, and understand and sign the informed consent.
排除标准
- •1. Patients with allergic constitution or known allergy to study drug / similar drug;
- •2. Patients who often use sedatives, sleeping pills or other addictive drugs; patients who have a history of drug abuse or positive drug abuse screening within 12 months before the first administration;
- •3. Alcoholics or patients who drink more than 14 units of alcohol per week (1 unit = 360ml of beer or 45ml of spirits or 150ml of wine with 40% of alcohol), patients who are addicted to smoking or quit smoking for less than 3 months, patients who are positive in alcohol breath test and nicotine test, and can not be banned from smoking or alcohol during the test period;
- •4. Patients who used any prescription medicine or Chinese herbal medicine supplement within one month before the first administration; patients who used any over-the-counter medicine (OTC), food supplement (including vitamins, calcium tablets, etc.) within two weeks before the first administration; patients who used contraceptive within two weeks before the first administration;
- •5. Patients who participated in other clinical trials and took the study drug within 3 months before the first administration;
- •6. The patients who participated in blood donation (including component blood donation) or lost 400ml blood within 3 months before the first administration, and the patients who participated in blood donation (including component blood donation) or lost 200ml blood within 1 month before screening, or received blood transfusion;
- •7. There was a history of autonomic nervous dysfunction and / or current history (such as recurrent syncope, palpitation, etc.) within 3 years before the first administration;
- •8. Patients with previous history of cardiovascular, liver, kidney, lung, digestive tract, nervous system diseases, and any history or condition that may significantly affect drug absorption, distribution, metabolism and excretion. Any medical history or condition that may be hazardous to the subjects participating in the trial. Researchers should consider the following medical history or conditions: inflammatory gastroenteritis, gastroesophageal reflux, gastrointestinal or rectal bleeding; history of pancreatic injury or pancreatitis; major surgical history such as gastrectomy, gastroenterostomy, or enterotomy; history of acute and chronic renal insufficiency, history of kidney transplantation;
- •9. Screening the patients with severe vomiting and diarrhea in the previous week;
- •10. Pregnant and lactating female subjects and those of childbearing age who could not use contraception as required;
- •11. Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive;
- •12. Patients who have special requirements for diet and fail to comply with the provided diet and corresponding regulations;
- •13. Subjects who refused to stop using any drink or food containing methylxanthine, such as coffee, tea, cola, chocolate, etc., 48 hours before the first administration until the end of the study;
- •14. Subjects who refused to discontinue any drink or food containing grapefruit 7 days before the first administration until the end of the study;
- •15. Subjects with difficulty in venous blood collection or intolerability to venipuncture;
- •16. Subjects with other unsuitable factors (including but not limited to the inability to understand the research requirements, poor compliance, weakness, etc.) judged by the researcher.
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