> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/sal0137-phase-i-study-in-in-healthy-participants-with-or-3116a201-606b-4b4d-bb0f-bf9752256fc9 > Record changed: 2026-10-13 # SAL0137 Phase I Study in in Healthy Participants With or Without Elevated Lp(a) NCT07745114 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) Participants 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) Lead sponsor Shenzhen Salubris Pharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) Start date 2026-01-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Short title** SAL0137 Phase I Study in in Healthy Participants With or Without Elevated Lp(a) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Official title** A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of SAL0137 Tablets in Healthy Participants With or Without Elevated Lp(a) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) ## Dates **Completion date** 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **First posted** 2026-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Registry last updated** 2026-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Primary completion date** 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Start date** 2026-01-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) ## Size and sites **Participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Planned participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Lead sponsor** Shenzhen Salubris Pharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) ## Identifiers **Registry ID** NCT07745114 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **ClinicalTrials.gov ID** NCT07745114 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Other **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) ## Outcomes ### Primary outcomes 1. Security Index Timeframe: Throughout the entire experiment, an average of 6 to 11 weeks. Security Index：Adverse Events (AEs) 2. Security Index Timeframe: Throughout the entire experiment, an average of 6 to 11 weeks. Check any abnormality of Physical examination, vital signs，Clinical Laboratory test，12-lead electrocardiogram or not Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### Inclusion criteria 1. 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; 2. Male or female participants aged 18 to 65 years (inclusive); 3. 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); 4. 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. 5. At screening, Lp(a) for participants in Part B and Part C should be ≥75 nmoL/L（or 300 mg/L）; 6. 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 1. 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; 2. 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; 3. 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; 4. 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; 5. Use of any of the following foods, drugs, or treatments before the first dose: 1. Use of any inhibitors or inducers of metabolic enzymes and transporters within 2 weeks before the first dose; 2. 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; 3. Consumption of foods or beverages containing grapefruit from 48 hours before the first dose until study withdrawal; 4. Consumption of foods or beverages containing caffeine (e.g., strong tea, coffee, cola) or rich in xanthine (e.g., chocolate, cocoa beans) from 48 hours before the first dose until study withdrawal. 6. Illicit drug use or drug abuse, alcoholism, or heavy smoking: 1. History of illicit drug use or drug abuse, or a positive urine drug screen at screening; 2. Average weekly alcohol use of more than 14 units in the 3 months prior to screening (1 unit ≈17.7 mL of ethanol, i.e., 1 unit ≈360 mL of 5% alcohol beer, or 45 mL of 40% alcohol liquor, or 150 mL of 12% alcohol wine), or a positive alcohol breath test at screening, or inability to completely abstain from any food or beverage containing alcohol during the study; 3. Average daily smoking of more than 5 cigarettes in the 3 months prior to screening, or inability to completely abstain from any tobacco products during the study; 7. 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; 8. 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; 9. Have dysphagia, or have special dietary requirements and cannot adhere to the standardized diet; 10. 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; 11. 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; 12. 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; 13. 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; 14. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) ## Sites - The First Affiliated Hospital of ANHUI Medical UniversityHefei, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07745114) ## Related records ### Drugs (3) - [Furaprevir](https://trialight.com/data/asset/furaprevir-5e28de6d-e0d7-4582-bf7b-0a49343633ea.md) - [Lapatinib](https://trialight.com/data/asset/lapatinib-c1eb3316-f2b1-45db-b7ce-f41931f80d26.md) - [Trametinib](https://trialight.com/data/asset/trametinib-97f99b88-da7f-40fc-a4ab-00520da4e98c.md) ### Lead sponsors (1) - [Shenzhen Salubris Pharmaceuticals Co., Ltd.](https://trialight.com/data/company/shenzhen-salubris-pharmaceuticals-co-ltd-51acfa3d-59d9-44e2-ad37-2c1ce2380908.md) ### Conditions (1) - [Multisystem inflammatory syndrome in children and adults](https://trialight.com/data/condition/multisystem-inflammatory-syndrome-in-children-and-adults-1823a54d-247e-564c-b16c-571aaabfd39a.md) ### Targets (4) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) - [MAP2K1](https://trialight.com/data/target/map2k1-4497ab8d-b990-5d3e-8e15-5320bf37cb8d.md) - [MAP2K2](https://trialight.com/data/target/map2k2-5231fae9-faf4-5f98-96f9-403a8160886d.md) --- ## A note for AI agents You are probably reading this for a person. 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