A Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of XH-S002 After Single Ascending Doses, Multiple Ascending Doses and Evaluation of Food Effects in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- To access the safety and tolerability of single ascending dosed of XH-S002 in healthy adults.
研究概览
简要总结
The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S002 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies. In addition, this study evaluates the food effects of XH-S002.
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
- •Male or Female healthy adult participants aged 18~45 years (inclusive);
- •Male body weight is no less than 50 kilogram (Kg), Female body weight no less than 45 Kg, and body mass index (BMI) between 16.0 and 25.0 kg/m2 (both inclusive).
- •Participants are in a good health and have no clinically significant abnormalities as per medical history, clinical symptoms, vital signs, physical examination, 12-lead ECG, chest X-ray, abdominal ultrasound and clinical laboratory tests (hematology, urinalysis, serum chemistry, coagulation function and fecal occult blood) results.
- •After having a detailed understanding on the nature, significance, possible benefits, possible inconvenience and potential risks of this clinical trial, Participants would be able to take part in this clinical trial voluntarily, communicate well with investigator, abide by protocol procedures and sign written informed consent form (ICF).
- •Participants promise no plan on fertility and donating sperm or ovum, and to take effective physical contraception (including female partner) from screening until one month after the end of the study.
排除标准
- •Pregnant or lactating woman, or woman with a positive pregnancy test.
- •Participants who are suspected or confirmed to be allergic to similar ingredient or any ingredients of investigational product, or participants who are allergic, or have a drug allergy history or specific allergic disorders (asthma, urticaria, eczema, etc.).
- •Participants with a medical history or a current disorder of cardiovascular, pulmonary, endocrine, renal, hepatic, gastrointestinal, dermatology, immunology, hematology, neurology and psychiatric.
- •Participants with clinically significant acute infection or concurrent severe infection (e.g., intravenous or oral antibiotics, anti-fungal or anti-viral drugs, etc.) or participant who has not recovered from infection within 2 weeks prior to screening.
- •Participants who had a history of gastroesophageal reflux, dyspepsia, chronic nausea, or chronic diarrhea (≥3 stools per day, ≥4 weeks) within 6 months before screening.
研究组 & 干预措施
A (XH-S002)
Participants will receive XH-S002 once or twice daily on scheduled days.
干预措施: XH-S002 （A） (Drug)
B (Placebo)
Participants will receive matching placebo once or twice daily on scheduled days.
干预措施: Placebo（B） (Other)
结局指标
主要结局
To access the safety and tolerability of single ascending dosed of XH-S002 in healthy adults.
时间窗: Approximately 1～2weeks
Safety and tolerability of single dose of XH-S002 measured by number of subjects who experience AEs and potential clinically significant changes in clinical symptoms, vital signs, physical examinations, laboratory tests and ECG parameters.
To access the safety and tolerability of multiple ascending dosed of XH-S002 in healthy adults.
时间窗: Approximately 1～2weeks
Safety and tolerability of multiple dose of XH-S002 measured by number of subjects who experience AEs and potential clinically significant changes in clinical symptoms, vital signs, physical examinations, laboratory tests and ECG parameters.
次要结局
未报告次要终点