A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of SHR0302 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.
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
- •Healthy subjects, age 18-45 years (inclusive);
- •The weight of the subject should be more than 50 kg, body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 24.
排除标准
- •Any condition that might interfere with the procedures or tests in the study
- •History of heart failure or renal insufficiency
- •Smoking; Drug or alcohol abuse
研究组 & 干预措施
single ascending doses
single ascending doses, oral tablets
干预措施: SHR0302 (Drug)
Placebo
Placebo Comparator, oral tablets
干预措施: SHR0302 placebo comparator (Drug)
结局指标
主要结局
Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers
时间窗: At protocol-specified times up to 24 hrs postdose
To characterize the effects of SHR0302 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in healthy volunteers.
The maximum plasma concentration (Cmax) of SHR0302
时间窗: At protocol-specified times up to 72 hrs postdose
Blood samples are taken on various timepoints to assess the pharmacokinetic parameters
The area under the plasma concentration-time curve (AUC) of SHR0302
时间窗: At protocol-specified times up to 72 hrs postdose
t1/2 of SHR0302
时间窗: At protocol-specified times up to 72 hrs postdose
Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.
时间窗: up to 72 hrs postdose
Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and blood circulation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.
次要结局
未报告次要终点