A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0167 in … (NCT07722299) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0167 in Healthy Participants
China120 participantsStarted 2026-07-21
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. For Part B, screening LDL-C ≥1.8 and ≤4.9 mmol/L and triglycerides (TG) ≤4.52 mmol/L;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events
Timeframe: through study completion, an average of 50 days
. The participant and the participant's partner have no plans for pregnancy during the study or for 3 months after the last dose of investigational product; agree to use effective contraception (hormonal contraceptives are prohibited during the study) to prevent pregnancy; and agree not to donate sperm or ova/oocytes for reproductive or assisted-reproduction purposes.
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:
. Any prescription drug, nonprescription drug, Chinese herbal medicine, or dietary supplement (including vitamins or health supplements) within 2 weeks or 5 half-lives, whichever is longer, before screening;
. Current or previous treatment with inclisiran sodium or another investigational small interfering RNA (siRNA) PCSK9 inhibitor;
. Treatment with an approved or investigational PCSK9 inhibitor or a microsomal triglyceride transfer protein inhibitor (e.g., lomitapide) within 12 months before screening;