NCT07521345招募中1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The number and severity of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This is a single-center, random, double blind, placebo control clinical study to evaluate the safety, tolerability pharmacokinetics and food effect of HSK55879 in healthy subjects
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
- •Able to understand the nature, purpose, and requirements of the study, as well as the potential risks and adverse reactions, and have signed the written informed consent form prior to the start of the study;
- •Healthy subjects aged 18 to 45 years (inclusive) at screening, male or female;
- •Body weight ≥50 kg for male subjects and ≥45 kg for female subjects at screening, with a body mass index (BMI) within the range of 19.0-28.0 kg/m² (inclusive);
- •Subjects (including their partners) agree to have no pregnancy plan from 14 days before screening until 3 months after the last dose, and agree to use reliable contraceptive measures during this period.
排除标准
- •Any history of disease that, in the investigator's judgment, may affect the safety evaluation of the subject or the in vivo disposition of the study drug,
- •Physical examination, vital signs, laboratory tests，abdominal ultrasound, or chest X-ray findings that are judged by the study physician to be clinically significant abnormalities;
- •Previous or current gastrointestinal, hepatic, renal, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion;
- •abnormal HbA1c at screening;
- •Abnormal liver function test results
- •Estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation <90 mL/min/1.73 m² at screening;
- •Routine 12-lead electrocardiogram (ECG) findings that are not consistent with normal cardiac conduction and function.
- •History of gastrointestinal diseases, with current symptoms of digestive discomfort ;
- •Current or past history of drug abuse, or a positive urine drug screen at screening;
- •Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening;
- •Pregnant or breastfeeding females;
- •Subjects who, in the investigator's opinion, have poor compliance or any other factor that makes them unsuitable for participation in this study.
研究组 & 干预措施
HSK55879
Experimental
Single oral dose of HSK55879, and food effect of HSK55879
干预措施: HSK55879 (Drug)
placebo
Placebo Comparator
Single oral dose of placebo, and food effect of placobo
干预措施: Placebo (Drug)
结局指标
主要结局
The number and severity of treatment emergent adverse events (TEAEs)
时间窗: 15 days after single dose
To assess the safety and tolerability of HSK55879 in healthy adult volunteers
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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