NCT03668509Unknown1 期
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR1459, in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single oral doses of SHR1459 determined by adverse events
研究概览
简要总结
This was a phase I, single-center, double-blind, randomized, placebo-controlled study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of the investigational medicinal product in healthy volunteers.
详细描述
The study originally planned to enroll 3 cohorts of 10 subjects each (N=30).
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
- •Male or female, of any ethnic origin, age ≥18 and ≤45 years of age;
- •BMI ≥19 and ≤26 kg/m2; Men's weight≥ 50kg, Women's weight ≥ 45kg;
- •Medical history without major pathology and determined to be in good health with no clinically significant findings as assessed by the Investigator; all clinical tests of blood, urine, ECG and X-ray are within the normal range or show no clinically relevant deviations as judged by the Investigator;
- •There is no birth plan during the trial and within 1 month after the completion of the trial, and the subject must agree to use one of the effective contraceptive methods;
- •Able to comprehend and abide by the study restrictions, and willing to sign an Informed Consent Form (ICF)
排除标准
- •Has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
- •Has a history of malignant or lymphoproliferative disorders;
- •Has a history of bleeding tendency or coagulopathy (eg, uncontrolled autoimmune hemolysis and thrombocytopenic purpura, severe hematopoietic defects, gastrointestinal bleeding), or recent bleeding events;
- •Has a history of stroke or intracranial hemorrhage within 6 months prior to screening;
- •Has any surgery performed within 3 months prior to screening, or during the study period and within 1 month after the end of the study;
- •Has a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune suppressive/defective, or psychiatric disorder as determined by the Investigator;
- •Has diseases affecting drug absorption, distribution, metabolism, and excretion (eg, gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, etc);
- •Has active tuberculosis by clinical symptoms, signs, laboratory tests, or X-ray examinations;
- •Has infections including acute and chronic infections, local infections such as sepsis, abscesses, and opportunistic infections that were clinically significant by the investigator in the 3 months prior to screening;
- •Has blood donation and donated ≥400 mL within 3 months before screening ; or received any blood product infusion; or received plasma exchange or blood cell clearance treatment;
研究组 & 干预措施
Cohort 1
Experimental
oral adminstration of SHR1459, dose 1
干预措施: SHR1459 (Drug)
Cohort 2
Experimental
oral adminstration of SHR1459, dose 2
干预措施: SHR1459 (Drug)
Cohort 3
Experimental
oral adminstration of SHR1459, dose 3
干预措施: SHR1459 (Drug)
结局指标
主要结局
Safety and tolerability of single oral doses of SHR1459 determined by adverse events
时间窗: within 4 days after single dose
Frequency and severity of AEs and serious AEs
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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