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.
Provide written informed consent before any study-specific procedure and be willing and able to comply with the requirements and restrictions specified in the informed consent form;
Male or female, 18 to 65 years of age, inclusive;
At screening, body weight ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) 19.0 to 28.0 kg/m², inclusive (BMI = weight [kg]/height [m]²);
At screening, no clinically significant findings on physical examination, vital signs, hematology, urinalysis, stool examination, serum chemistry, creatine kinase isoenzyme testing, coagulation tests, serology, or 12-lead ECG, as determined by the investigator; lipid parameters are excepted for Part B;
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;