This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SAL0167 following single and multiple dose administration in healthy participants. The study consists of two parts (Part A and Part B) with 120 participants planned to be enrolled. Possible adjustments to sample size, treatment duration will depend upon emerging data.
Inclusion Criteria:
Exclusion Criteria:
Any clinically significant disease or medical history that, in the investigator's judgment, could interfere with study completion, including respiratory, cardiovascular, gastrointestinal, genitourinary, hematologic, endocrine, neurologic, psychiatric, malignant, or infectious disease; any disease or surgical history that could significantly alter drug absorption, metabolism, or elimination (e.g., gastrointestinal surgery, renal surgery, cholecystectomy, or another surgery considered likely to affect drug disposition); or habitual constipation or diarrhea;
A history of a gastrointestinal disorder that, in the investigator's judgment, could affect food or drug absorption, such as recurrent vomiting, inflammatory bowel disease, chronic intestinal disease associated with malabsorption, Roemheld syndrome, or severe hernia;
Severe cardiovascular or cerebrovascular disease within 12 months before screening, including decompensated heart failure, unstable angina, stroke or transient ischemic attack, acute myocardial infarction, or severe arrhythmia; a history of coronary artery bypass grafting or percutaneous coronary intervention; or planned cardiac stent placement or angioplasty during the study;
A clinically significant acute drug or food allergic reaction within 2 weeks before screening; a history of allergy to two or more drugs, foods, or pollens; a history of allergic disease (e.g., asthma, urticaria, or eczematous dermatitis); or known or suspected allergy, hypersensitivity, or clinically significant reaction to SAL0167, a compound of the same class, placebo, or any excipient, as determined by the investigator;
Use of any of the following foods, drugs, or treatments:
Receipt of a live vaccine, live-attenuated vaccine, or vaccine containing a live viral component within 3 months before screening, or planned receipt of such a vaccine during the study or within 1 month after study completion;
Major trauma or major surgery (e.g., requiring general anesthesia) within 3 months before screening, or planned surgery during the study or within 3 months after study completion, except a procedure performed under local anesthesia;
Participation in an interventional clinical study, including a study of an investigational drug or vaccine, another clinical study of SAL0167, or another cohort of this study, and receipt of investigational product within 3 months before screening;
Blood donation (including apheresis) or blood loss ≥400 mL within 3 months before screening; blood donation or blood loss ≥200 mL, or receipt of a blood transfusion, within 1 month before screening; or planned donation of blood or blood components during the study or within 1 month after study completion;
Difficulty with blood collection, inability to tolerate repeated venipuncture, or a clinically significant history of needle or blood phobia, as determined by the investigator;
Difficulty swallowing or dietary requirements that preclude compliance with the standardized diet;
Pregnant or breastfeeding female; positive pregnancy test in a female participant of childbearing potential; or unprotected sexual intercourse within 14 days before screening in a female participant of childbearing potential;
Drug or substance abuse, excessive alcohol use, or heavy smoking, as evidenced by any of the following:
QTcF >450 ms for males or >470 ms for females;
Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum-specific antibody;
Poor anticipated compliance, as determined by the investigator, or any other factor that makes the participant unsuitable for the study.
nflcyljd@smu.edu.cn13926186470
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