SAL0137 Phase I Study in in Healthy Participants With or Without Elevated Lp(a) (NCT07745114) | Clinical Trial Compass
Active — Not RecruitingPhase 1
SAL0137 Phase I Study in in Healthy Participants With or Without Elevated Lp(a)
China144 participantsStarted 2026-01-04
Plain-language summary
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.
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
. 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）;
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
Security Index
Timeframe: Throughout the entire experiment, an average of 6 to 11 weeks.
2
Security Index
Timeframe: Throughout the entire experiment, an average of 6 to 11 weeks.
. 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.
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:
. 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;