SAL0137 Phase I Study in in Healthy Participants With or Without Elevated Lp(a)

NCT07745114 | Active Not Recruiting Phase 1

• 1 other identifier: SAL0137A101
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants; Elevated Lp(a)

Keywords

SAL0137; Single and multiple ascending dose

Outcome Measures

Primary Outcomes (2)

• Security Index

  Security Index：Adverse Events (AEs)

  Throughout the entire experiment, an average of 6 to 11 weeks.

• Security Index

  Check any abnormality of Physical examination, vital signs，Clinical Laboratory test，12-lead electrocardiogram or not

  Throughout the entire experiment, an average of 6 to 11 weeks.

Study Arms (2)

Part A

EXPERIMENTAL

Drug: Single Ascending Dose; Drug: Once Daily (QD), Multiple Ascending Dose (MAD)

Part B

EXPERIMENTAL

Drug: Single Ascending Dose; Drug: Once Daily (QD), Multiple Ascending Dose (MAD)

Interventions

Single Ascending Dose DRUG

SAL0137

Part A

Once Daily (QD), Multiple Ascending Dose (MAD) DRUG

SAL0137

Part A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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）;
• 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.

You may not qualify if:

• 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;
• 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.
• Illicit drug use or drug abuse, alcoholism, or heavy smoking:
• History of illicit drug use or drug abuse, or a positive urine drug screen at screening;
• 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;
• 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;
• 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;
• 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;

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of ANHUI Medical University

Hefei, Anhui, 230088, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 4, 2026
• Study Start: January 4, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)