To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects With Fasting Single or Multiple Oral Administration
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
This is a study to evaluate the safety, tolerability, pharmacokinetics, and food effects of SHEN211 tablet in healthy subjects after fasting single or multiple oral administration
详细描述
The whole trial consisted of three parts: Part 1 was a single-center, randomized, double-blind, placebo-controlled, single-dose dose increasing safety, tolerability and pharmacokinetic test; Part 2 was a single-center, randomized, double-blind, placebo-controlled, multiple-dose safety, tolerability and pharmacokinetic study. Part 3 is a single-dose, randomized, open, two-phase, double-cross, two-sequence design trial of the effects of food on the main PK parameters of SHEN211 tablets in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Male or female healthy subjects, ages 18-55 (including boundary values)
- •The body weight of male subject is not less than 50.0kg, the body weight of female subject is not less than 45.0kg,Body mass index(BMI) in the range of 19.0 ~28.0kg/m2[BMI= weight (kg)/height 2 (m2)] (including the critical value)
- •Subjects (including male subjects) are willing to be childfree from screening until 6 months after the last dose of the study drug, voluntarily use effective contraception (see Appendix I), and have no sperm donation plans; Women of childbearing age had to be assessed by a specialist as not pregnant and within 7 days of the start of their last menstrual period before enrollment.
- •Sign informed consent before screening, fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the requirements of the test protocol.
排除标准
- •Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry), coagulation function, infection marker examination, pregnancy examination (female only),12-lead electrocardiogram examination, chest X-ray examination, were determined by the investigator to be abnormal and clinically significant
- •Any medical history or present medical history that may affect the subject's safety evaluation or study of the drug in vivo process, including but not limited to neurological/psychiatric, respiratory, cardiovascular and cerebrovascular systems, digestive system (any history of gastrointestinal disorders that affect drug absorption), blood and lymphatic system, liver and kidney function, endocrine system, and immune system disorders
- •Those who had surgery within 3 months prior to screening or planned to have surgery during the study period, and those who had surgery that would affect drug absorption, distribution, metabolism, or excretion;
- •Have a history of allergies to food, drugs, etc., or are known to be allergic to any component of this product
- •People who have used any prescription drugs, over-the-counter drugs, Chinese herbs and health products within 2 weeks before screening;
- •Any drug that inhibits or induces liver metabolism of drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) used within 28 days prior to screening; Inhibitors -SSRI antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines);
- •Those who received vaccination within 1 month prior to screening or planned to receive vaccination during the study period;
- •Those who consumed an average of more than 14 units of alcohol per week (1 unit of alcohol ≈360mL beer or 45mL spirits with 40% alcohol or 150mL wine) in the three months prior to screening, or could not abstain during the test period, or had a positive alcohol breath at baseline;
- •People who smoked an average of more than 5 cigarettes per day in the 3 months prior to the first administration of the study drug, or who could not stop using any tobacco products during the trial period;
- •Blood donation or blood loss (≥400mL) within 3 months before screening, or blood transfusion;
- •Those with a history of drug abuse within 6 months prior to screening;
- •Those who had used drugs in the 3 months prior to screening, or who had positive urine screening at baseline;
- •Participated in other drug clinical trials within 3 months prior to screening;
- •Excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups on average, 1 cup ≈250mL) in the 3 months before screening;
- •Those who have special dietary requirements and cannot accept a unified diet;
- •Dysphagia;
- •Those with a history of infection (except a history of infection with the novel coronavirus);
- •People who are lactose intolerant (those who have had diarrhea from drinking milk);
- •Patients who cannot tolerate venipunction or have a history of needle fainting or blood fainting;
- •Female subjects who are pregnant or breastfeeding;
- •Participants considered inappropriate for clinical trials.
研究组 & 干预措施
（Trial group）-SHEN211 tablets
part 1：Four dose groups were set up: 110mg,330mg, 550mg and 770mg, each group was intended to include 2 subjects and was administered orally. SHEN211 tablets in the corresponding dose group were given on fasting in the morning of D1. PK blood collection and related tests were completed on day 8 (D8), PK and safety tests were completed on day 10 (D10), and telephone follow-up was performed on day 14 (D14±1).
part 2：Two dose groups were set up with 8 subjects in each group. In the first dose group, 330mg SHEN211 tablets D1 and 110mgSHEN211 tablets D2 ~ D5 were taken orally once a day (QD). The second dose group was taken orally 660mg SHEN211 tablets on D1 and 220mg SHEN211 tablets from D2 to D5, once a day (QD). PK samples were collected before and after administration, and safety observation was performed up to 8 days after the last administration.
干预措施: SHEN211 tablets (Drug)
（Placebo group）-placebo tablets
part 1：Four dose groups were set up: 110mg,330mg, 550mg and 770mg, each group was intended to include 2 subjects and was administered orally. placebo tablets in the corresponding dose group were given on fasting in the morning of D1. PK blood collection and related tests were completed on day 8 (D8), PK and safety tests were completed on day 10 (D10), and telephone follow-up was performed on day 14 (D14±1).
part 2：Two dose groups were set up with 8 subjects in each group. In the first dose group, 330mg placebo tablets D1 and 110mg placebo tablets D2 ~ D5 were taken orally once a day (QD). The second dose group was taken orally 660mg placebo tablets on D1 and 220mg placebo tablets from D2 to D5, once a day (QD). PK samples were collected before and after administration, and safety observation was performed up to 8 days after the last administration.
干预措施: SHEN211 placebo tablets (Drug)
（Food influence group）-SHEN211 tablets
The dose of SHEN211 tablets 330mg was intended to be selected in this experiment. Subjects in group A took SHEN211 tablets 330mg orally on an empty stomach in the morning of the first day of the experiment (the first cycle). On the morning of the 12th day of the trial (the second cycle), SHEN211 tablets 330mg were taken orally once, 30min after starting to eat a high-fat high-calorie meal; Subjects in group B took SHEN211 tablets 330mg orally once in the morning of the first day of the trial (the first cycle) when they started to eat A high-fat and high-calorie meal for 30min, and took SHEN211 tablets 330mg orally in the morning of the 12th day of the trial (the second cycle) on an empty stomach.
干预措施: SHEN211 tablets (Drug)
结局指标
主要结局
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Up to day 63
Safety and Tolerability as assessed by AEs and SAEs
次要结局
- Tmax(Up to day 63)
- AUC(Up to day 63)
- λz(Up to day 63)
- Cmax(Up to day 63)
- t1/2(Up to day 63)