NCT07745114进行中（未招募）1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of SAL0137 Tablets in Healthy Participants With or Without Elevated Lp(a)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Security Index
研究概览
简要总结
This study is divided into 3 parts: Part A, Part B, and Part C. Part A is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of SAL0137 tablets; Part B is a randomized, double-blind, placebo-controlled, multiple ascending dose study with once-daily administration for 14 consecutive days to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple QD oral doses of SAL0137 tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have fully understood the study and voluntarily sign the written informed consent form, and are able to comply with the requirements and restrictions listed in the informed consent form;
- •Male or female participants aged 18 to 65 years (inclusive);
- •At screening, weight ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) between 19.0 and 28.0 kg/m2 (inclusive; BMI = weight ÷ height2);
- •At screening, results of all examinations (including physical examination, vital signs, hematology, urinalysis, blood chemistry, coagulation tests, viral serology and 12-lead electrocardiogram) other than Lp(a) are normal or have minor abnormalities judged by the investigator to be of no clinical significance, where fibrinogen should not be below the lower limit of the normal range.
- •At screening, Lp(a) for participants in Part B and Part C should be ≥75 nmoL/L（or 300 mg/L）;
- •The participants or their partners have no plans for pregnancy during the study and for 6 months after the last dose of the study drug, and are willing to use effective contraceptive measures (the use of contraceptive pills is prohibited during the study). In addition, the participants will not donate sperm or eggs (oocytes) for reproductive or assisted reproductive purposes.
排除标准
- •Pregnant or lactating women, or women of childbearing potential with a positive pregnancy screening result, or female participants of childbearing potential who have had unprotected sexual intercourse within 14 days before the first dose;
- •Any disease (e.g., acute gastritis, gastrointestinal ulcer, Henoch-Schonlein purpura, lupus erythematosus, etc.) or medical history (e.g., history of intracranial haemorrhage, history of intraocular haemorrhage, history of haemophilia, history of von Willebrand disease, etc.) that, in the investigator's judgment, could alter or increase the haemorrhagic diathesis;
- •History of clinically significant acute drug or food allergy within 2 weeks before screening, or allergic diathesis (e.g., allergy to two or more drugs, foods, or pollens), or a history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or known or suspected allergy, hypersensitivity, or clinically significant reaction to the investigational product (including similar drugs or the control drug) or any of its excipients, as judged by the investigator;
- •Positive result for any of the following tests: hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum specific antibody;
- •Use of any of the following foods, drugs, or treatments before the first dose:
- •Use of any inhibitors or inducers of metabolic enzymes and transporters within 2 weeks before the first dose;
- •Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and dietary supplements (including vitamins, health products, etc.) within 2 weeks before the first dose;
- •Consumption of foods or beverages containing grapefruit from 48 hours before the first dose until study withdrawal;
- •Consumption of foods or beverages containing caffeine (e.g., strong tea, coffee, cola) or rich in xanthine (e.g., chocolate, cocoa beans) from 48 hours before the first dose until study withdrawal.
- •Illicit drug use or drug abuse, alcoholism, or heavy smoking:
- •History of illicit drug use or drug abuse, or a positive urine drug screen at screening;
- •Average weekly alcohol use of more than 14 units in the 3 months prior to screening (1 unit ≈17.7 mL of ethanol, i.e., 1 unit ≈360 mL of 5% alcohol beer, or 45 mL of 40% alcohol liquor, or 150 mL of 12% alcohol wine), or a positive alcohol breath test at screening, or inability to completely abstain from any food or beverage containing alcohol during the study;
- •Average daily smoking of more than 5 cigarettes in the 3 months prior to screening, or inability to completely abstain from any tobacco products during the study;
- •Blood donation (including component donation) or blood loss ≥400 mL within 3 months before screening, blood donation (including component donation) or blood loss ≥200 mL or have received a transfusion within 1 month before screening, or plans to donate blood or blood components during the study or within 1 month after the end of the study;
- •Difficulty with blood sampling or inability to tolerate multiple venipunctures, or a clinically significant history of needle or blood phobia as judged by the investigator;
- •Have dysphagia, or have special dietary requirements and cannot adhere to the standardized diet;
- •Have received a live vaccine, live attenuated vaccine, or any vaccine with live viral components within 3 months before screening, or plan to receive such vaccines during the study or within 1 month after the end of the study;
- •Have experienced severe trauma or have received major surgery (e.g., requiring general anaesthesia) within 3 months before screening, or plan to undergo surgery (except for surgery under local anaesthesia) during the study or within 3 months after the end of the study;
- •Have participated in or are currently participating in any interventional clinical study (including investigational drugs or vaccines, as well as other clinical studies of this investigational product or other groups of this study) and received an investigational product within 3 months before screening; or have received siRNA drugs within the past 12 months; or have received antisense oligonucleotide drugs/antibody drugs within the past 6 months;
- •Presence of other clinically significant diseases or medical history that, in the investigator's judgment, may interfere with the participant's ability to complete this study (including diseases or disorders involving the respiratory, cardiovascular, digestive, urogenital, hematologic, endocrine, neurological, and psychiatric systems, as well as malignancies), or other diseases or medical history that may significantly alter drug absorption, metabolism, or clearance (e.g., history of surgery judged to potentially affect the in vivo disposition of the drug, such as gastrointestinal surgery, renal surgery, or cholecystectomy), or infectious diseases;
- •Male study participants with QTCF > 450 ms, female study participants with QTCF > 470 ms; 15）Poor compliance as judged by the investigator, or any other factors that make the participant unsuitable for this study.
结局指标
主要结局
Security Index
时间窗: Throughout the entire experiment, an average of 6 to 11 weeks.
Security Index：Adverse Events (AEs)
次要结局
未报告次要终点
研究者
研究点 (1)
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