Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change of 12-lead ECG
研究概览
简要总结
The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study.
The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18≤Age≤45, male or female;
- •Body weight (> 45.0 kg (female) or 50.0 kg (male), 19.0 kg/m2 (< BMI) = 26.0 kg/m2);
- •Subjects with normal clinical significance by medical history, vital signs, physical examination and laboratory examination;
- •All subjects who adopt effective non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs, etc.) from the signing of informed consent to three months after the end of the study;
- •Subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal.
排除标准
- •Female subjects: pregnant or lactating, or planned pregnancy; male subjects: their partner planned pregnancy, or planned to donate sperm;
- •Have neurological or psychiatric diseases history, or have serious cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive, immune and other systemic diseases history;
- •Surgery history within six months before signing the informed consent;
- •Allergic history to more than one drug or other serious allergic rhistory.
- •Subjects with a QTc interval greater than 450 ms (male) or 470 MS (female), or with a history of prolonged QTc interval;
- •Positive with serum immunological test for HBsAg, Anti-HCV, Anti-HIV or Anti-TP;
- •History of drugs or drug abuse or alcoholics;
- •History of blood donation more than 200 mL within 8 weeks before signing informed consent;
- •Subjects participating in other clinical trials, or who have participated in any other clinical trials of drugs within three months before signing informed consent;
- •Not suitable for this trial according to the investigator.
研究组 & 干预措施
200mg
Tablets, Oral, 200mg, single dose
干预措施: 200mg (Drug)
25mg
Tablets, Oral, 25mg, single dose
干预措施: 25mg (Drug)
50mg
Tablets, Oral, 50mg, single dose
干预措施: 50mg (Drug)
100mg
Tablets, Oral, 100mg, single dose
干预措施: 100mg (Drug)
400mg
Tablets, Oral, 400mg, single dose
干预措施: 400mg (Drug)
800mg
Tablets, Oral, 800mg, single dose
干预措施: 800mg (Drug)
结局指标
主要结局
Change of 12-lead ECG
时间窗: 0, 0.5, 1, 2, 4, 8, 24, 48, 72 hours
To assess the change of 12-lead ECG (PR，QRS，QT，QTc) after administration of SYHA1402
Chagne of blood routine
时间窗: 24, 48, 72 hours
To assess the change of blood routine after administration of SYHA1402
Change of systolic blood pressure and diastolic blood pressure
时间窗: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess the change of blood pressure after administration of SYHA1402
Change of physical examination
时间窗: 24, 48, 72 hours
To assess the change of physical examination (including cardiovascular system, chest and lung, abdomen, nervous system, skeletal muscle system, etc) after administration of SYHA1402
Change of blood biochemistry
时间窗: 24, 48, 72 hours
To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402
Change of pulse
时间窗: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess pulse after administration of SYHA1402
Change of heart rate
时间窗: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess the change of heart rate after administration of SYHA1402
Change of body temperature
时间窗: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess the change of body temperature after administration of SYHA1402
Change of urinary routine
时间窗: 24, 48, 72 hours
To assess the change of urinary routine after administration of SYHA1402
次要结局
- Peak concentration (Cmax)(10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours)
- Peak time (Tmax)(10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours)
- Half time (t1/2)(10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours)
- Apparent clearance (CL/F)(10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours)
- Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402(10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours)
- Area under the plasma concentration-time curve (AUC0-72h)(10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours)