A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Describe Pharmacokinetics/Pharmacodynamics, and the Safety and of SPH3127 Tablet in Chinese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Assessment of safety parameters [adverse events, laboratory data, vital signs, and ECG]
研究概览
简要总结
- To evaluate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) characteristics of SPH3127 dose escalation, a single oral dose in Chines healthy volunteers.
- To explore the appropriate dose and provide the basis for the subsequent clinical trials.
详细描述
48 healthy volunteers will participate in this trial. Participants will be divided into 6 group, 25mg，50mg，100mg，200mg，400mg and 800mg. In each group, 6 participants will take SPH3127 tablet, while 2 participants will take placebo randomly. Safety data and PK/PD data will be collected as protocol described.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults,age >=18 years.Single gender should no less than a third of total subjects in each group.
- •BMI should be18 to 24 kg/m2 (including threshold), allowing the lowest weight 50 kg (including threshold) for the male and 45 kg (including threshold) for the female.
- •understand details of significance, benefit, inconvenience and potential danger of the research program, voluntarily signed informed consent.
排除标准
- •during pregnancy, nursing mothers, and plans to test in the first 6 months (grant) pregnant;
- •abnormal results in physical examination, laboratory examination and have clinical significance (such as: liver function examination - aspartate aminotransferase (AST)/alanine aminotransferase (ALT) is more than 1.5 times of the upper limit of normal).
- •with cardiovascular, liver, kidney, gastrointestinal, nervous system, blood system and familial blood disease, thyroid dysfunction or abnormal mental illness;
- •has a history of drug allergy and allergic constitution;
- •took birth control pills within 6 weeks;
- •used any drugs (including Chinese herbal medicine) within 1 week;
- •participated in blood donation within 2 months ;
- •participated in any drug clinical trials (as subjects) within three months;
- •any positive result in virus serology check: human immunodeficiency virus antigen antibody (HIV Ag/Ab) 、hepatitis c virus (HCV) - IgG antibody to IgG, hepatitis b surface antigen (HBsAg) and treponema pallidum antibody (TP);
- •addicted to cigarettes, alcohol, drink coffee, strong tea and drug abuse;
- •researchers think that exists any unfavorable factors to participate in the test.
研究组 & 干预措施
25 mg SPH3127 tablet-Dose 1
6 Volunteers, Single dose of SPH3127 tablet, 25mg, po. 1 tablet.
2 Volunteers, Single dose of Placebo tablet, 25mg, po. 1 tablet.
干预措施: SPH3127 (Drug)
50 mg SPH3127 tablet-Dose 2
6 Volunteers, Single dose of SPH3127 tablet, 50mg, po. 1 tablet.
2 Volunteers, Single dose of Placebo tablet, 50mg, po. 1 tablet.
干预措施: SPH3127 (Drug)
100 mg SPH3127 tablet-Dose 3
6 Volunteers, Single dose of SPH3127 tablet, 100mg, po. 1 tablet.
2 Volunteers, Single dose of Placebo tablet, 100mg, po. 1 tablet.
干预措施: SPH3127 (Drug)
200 mg SPH3127 tablet-Dose 4
6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 2 tablet.
2 Volunteers, Single dose of Placebo tablet, 100mg, po. 2 tablet.
干预措施: SPH3127 (Drug)
400 mg SPH3127 tablet-Dose 5
6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 4 tablet.
2 Volunteers, Single dose of Placebo tablet, 100mg, po. 4 tablet.
干预措施: SPH3127 (Drug)
800 mg SPH3127 tablet-Dose 6
6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 8 tablet.
2 Volunteers, Single dose of Placebo tablet, 100mg, po. 8 tablet.
干预措施: SPH3127 (Drug)
结局指标
主要结局
Assessment of safety parameters [adverse events, laboratory data, vital signs, and ECG]
时间窗: 10 days
adverse events, laboratory data, vital signs, and ECG et al.
次要结局
- Assessment of PK parameter 1 [Cmax](2 days)
- Assessment of PD parameter 1 [Inhibition of Renion Activity (%)](2 days)
- Assessment of PD parameter 2 [Blood pressure (mmHg)](2 days)
- Assessment of PK parameter 2 [tmax](2 days)
- Assessment of PK parameter 3 [AUC](2 days)