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.
Inclusion Criteria:
Exclusion Criteria:
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:
Illicit drug use or drug abuse, alcoholism, or heavy smoking:
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.
Hefei, Anhui 230088, China
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