A Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of HS-10506 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 主要终点
- Number of participants with clinically significant change from baseline in vital signs
研究概览
简要总结
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral HS-10506 in Chinese Healthy Subjects.
详细描述
This is a phase 1a, first-in-human, double-blind, placebo-controlled clinical trial. The primary objective is to assess the safety, tolerability and pharmacokinetic of single dose HS-10506 in healthy subjects. The secondary objective is to observed pharmacokinetic parameters and metabolites after single dose of HS-10506.
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, Care Provider)
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 participants aged from 18 to 45 years
- •Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily signed Informed Consent Form
- •Males' weight ≥ 50kg, females' weight ≥ 45kg, body mass index {BMI, BMI=weight/height 2 (kg/m2)} is controlled within the range of 18~28 (including the critical value)
- •During the study and for 3 months after receiving the last dose of study drug, subjects must agree not to donate sperm or eggs, not to plan to have children, and to use an effective method of contraception
排除标准
- •Has a history of chronic or serious disease from neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system or tumor
- •Has taken any drugs, including prescription drugs, over-the-counter drugs, herbal preparations, some health products or inhibitor/inducer of CYP3A4 or CYP3A5, within 2 weeks (or 5 half-lives) before screening and throughout the study period
- •Has clinically significant ECG abnormalities, such as QT interval corrected according to Fridericia formula(QTcF), >450 ms (males), >470 ms (females)
- •Has current manifestation of blood pressure or pulse abnormalities in resting state: such as systolic blood pressure <90 mmHg or ≥140 mmHg, diastolic blood pressure <60 mmHg or ≥90 mmHg, pulse <55 bpm or >100 bpm
研究组 & 干预措施
HS-10506
Healthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1.
干预措施: HS-10506 (Drug)
HS-10506 Placebo
Healthy participants will be enrolled in dose escalation cohorts. Healthy participants will be receive either HS-10506 or matching placebo on Day 1.
干预措施: HS-10506 Placebo (Drug)
结局指标
主要结局
Number of participants with clinically significant change from baseline in vital signs
时间窗: From baseline to Day 3
Number of participants with clinically significant abnormalities in physical examination
时间窗: From baseline to Day 3
Changes in 12-lead electrocardiogram from before to after dosing
时间窗: From baseline to Day 3
Descriptive statistics of heart rate, PR interval, QT interval, and QTcF for observed values and changes from baseline will be summarized at each scheduled time point.
Change in Stanford Sleepiness Scale score from before to after dosing
时间窗: From baseline to 4 hours after dosing
Stanford Sleepiness Scale（SSS） is a simple and accurate method used to assess sleepiness symptom. Respondents use the scale from 1 to 7 to indicate their current level of sleepiness. Higher scores mean a higher level of sleepiness. Descriptive statistics of SSS scores and changes from baseline will be summarized at each scheduled time point.
Incidence and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events leading to discontinuation from the study, and their correlation with the investigational drug
时间窗: Screening until Trail phase (up to 5 weeks)
The definition of adverse event \[AE\] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The definition of serious adverse event \[SAE\] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
次要结局
- Time to reach maximum plasma concentration (Tmax)(up to 48 hours after dosing)
- Area under the concentration-time curve from time zero to last time of quantifiable concentration（AUC0-t）(up to 48 hours after dosing)
- Area under the concentration-time curve from time zero to infinity（AUC0-∞）(up to 48 hours after dosing)
- Terminal Rate Constant（λz）(up to 48 hours after dosing)
- Elimination Halflife (T1/2)(up to 48 hours after dosing)
- Apparent clearance（CL/F）(up to 48 hours after dosing)
- Apparent Volume of Distribution（Vd/F）(up to 48 hours after dosing)
- Mean Residence Time(MRT)(up to 48 hours after dosing)
- Observed maximum plasma concentration (Cmax)(up to 48 hours after dosing)