A Phase I, Randomized, Double-blinded, Placebo-controlled Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Administered HS-10360 in Healthy Subjects.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 76
- 主要终点
- Electrocardiogram
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of single and multiple oral administered doses of HS-10360 in healthy subjects.
详细描述
This is a phase I, randomized, double-blinded, placebo-controlled, single ascending doses (SAD) study followed by multiple ascending doses (MAD) clinical trial to assess the safety, tolerability, and pharmacokinetics of HS-10360 tablet (s) in Chinese healthy adult subjects.
Approximately five sequential dose levels will be evaluated in SAD phase. Two sentinel subjects will be enrolled in the first cohort and minimal 72 hours post-dose safety data will be evaluated before the remaining subjects are enrolled in this cohort. Approximately three sequential dose cohorts (the specific dose levels should be further determined according to the SAD results) will be evaluated in MAD phase. Each subject will receive only one dose regimen in this study. Safety data up to Day12 (±2) in SAD and up to Day28 (±2) in MAD will be reviewed prior to the next dose level. The number of Cohorts in SAD and MAD would be adjusted based on the assessment of SRC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- •Healthy male or female subjects between 18 and 45 years old;
- •Body weight more than 50.0kg (male) or 45.0kg (female), body mass index (BMI) within the range of 19.0~26.0kg/m2 (both inclusive);
- •Subjects and their partners should have no fertility plan, no sperm or ootid donation plan and must use highly effective contraceptive methods (such as abstinence, condom, etc.) from the screening period to 6 months post-trial;
- •Additional inclusion criteria apply;
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •Clinically significant abnormalities in baseline results of laboratory evaluations;
- •Subjects has a positive result of any of following virology tests (hepatitis B surface antigen HBsAg, hepatitis B core antibody HBcAb, hepatitis C virus HCV antibody, human immunodeficiency virus HIV antibody, Treponema pallidum antibody TP-Ab) ;
- •History or evidence of clinically significant cardiovascular, pulmonary, endocrine, gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especially those conditions that interfere with absorption, metabolism and/or excretion of the study drug, determined by the investigator;
- •Any previous or current severe infection, such as cellulitis, pneumonia, sepsis etc., requiring hospitalization and/or intravenous antibiotic treatment, within 30 prior to the screening period;
- •Have participated in clinical trials of other drugs or medical devices within 3 months or within 5 half-lives of other drugs before screening (if 5 half-lives exceed 3 months);
- •History or presence of allergy, especially known allergy to investigational product components or other JAK inhibitors;
- •Had taken any medication, including prescription, over-the-counter, herbal, dietary supplements, or vaccines, within the previous 2 weeks; or within the five half-lives of the aforementioned drugs prior to randomization;
研究组 & 干预措施
HS-10360
Either single or multiple doses of varying dose levels
干预措施: HS-10360 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Electrocardiogram
时间窗: Baseline to end of follow-up (a maximum of 42 days)
Number of participants who experienced a clinically significant electrocardiogram (ECG) result
Serious treatment-emergent adverse events (TEAE)
时间窗: Baseline to end of follow-up (a maximum of 42 days)
Number of participants who experience one or more serious treatment-emergent adverse events (TEAE)
Clinical laboratory measurements
时间窗: Baseline to end of follow-up (a maximum of 42 days)
Number of participants who experienced a clinically significant clinical laboratory measurements
Vital Signs
时间窗: Baseline to end of follow-up (a maximum of 42 days)
Number of participants who experienced a clinically significant vital sign measurement
Moderate or severe treatment-emergent adverse events (TEAE)
时间窗: Baseline to end of follow-up (a maximum of 42 days)
Number of participants who experience one or more moderate or severe treatment-emergent adverse events (TEAE)
Treatment-emergent adverse events (TEAE)
时间窗: Baseline to end of follow-up (a maximum of 42 days)
Number of participants who experience one or more treatment-emergent adverse events (TEAE)
次要结局
- SAD pharmacokinetic endpoints:(Day1-Day6(SAD))
- MAD pharmacokinetic endpoints:(Day1-Day19)