Elevated Lipoprotein(a)Phase 1NCT07804160
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0195 Injection in Participants With or Without Elevated Lipoprotein(a)
A Phase 1 study testing SAL0195 Injection 30 mg, SAL0195 Injection 100 mg and SAL0195 Injection 300 mg in people with Elevated Lipoprotein(a), run by The Third Xiangya Hospital of Central South University.
Trial summary
This is a randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of SAL0195 injection in participants with or without elevated lipoprotein(a) [Lp(a)]. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Lipoprotein(a)
- What is being tested?
- SAL0195 Injection 30 mg, SAL0195 Injection 100 mg and SAL0195 Injection 300 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 31 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Participants who have fully understood the study, voluntarily provided written informed consent, and are able to comply with the requirements and restrictions specified in the informed consent form.
- 2. Male or female participants aged 18 to 65 years, inclusive.
- 3. At screening, male participants must weigh at least 50 kg and female participants must weigh at least 45 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m², inclusive.
- 4. For participants required to have elevated lipoprotein(a) [Lp(a)], screening Lp(a) must be ≥75 nmol/L or ≥30 mg/dL. The 30 mg dose cohort may include participants with or without elevated Lp(a), as specified in the protocol.
- 5. At screening, physical examination, vital signs, hematology, urinalysis, serum chemistry, coagulation tests, viral serology, and glycated hemoglobin results, except for Lp(a), must be normal or show only minor abnormalities considered not clinically significant by the investigator. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must not exceed the upper limit of normal.
- 6. Twelve-lead electrocardiogram findings must be normal or considered not clinically significant by the investigator, with QTcF <450 ms.
- 7. Participants and their partners must have no plans for pregnancy during the study and for 6 months after administration of the study intervention. Participants must agree to use effective contraception during this period. Hormonal contraceptives are prohibited during the study. Participants must not donate sperm or ova for reproductive or assisted reproductive purposes.
Who cannot join
- 1. Women who are pregnant or breastfeeding; women of childbearing potential with a positive pregnancy test; or women of childbearing potential who have had unprotected sexual intercourse within 14 days before the first dose.
- 2. Any disease or medical history considered by the investigator to alter or increase bleeding tendency, including but not limited to acute gastritis, gastrointestinal ulcer, allergic purpura, systemic lupus erythematosus, previous intracranial or intraocular hemorrhage, hemophilia, or von Willebrand disease.
- 3. A clinically significant acute drug or food allergic reaction within 2 weeks before screening; an allergic constitution, such as allergy to two or more drugs, foods, or pollens; a history of allergic disease such as asthma, urticaria, or eczematous dermatitis; or known or suspected hypersensitivity or clinically significant reaction to the study intervention, related drugs, placebo, or any excipient.
- 4. Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum-specific antibody.
- 5. Any of the following prior to the first dose:
- Administration of a small interfering RNA (siRNA) or antisense oligonucleotide within 18 months;
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- Use of any metabolic enzyme or transporter inhibitor or inducer within 2 weeks;
- Use of any prescription drug, over-the-counter drug, traditional Chinese medicine, herbal product, dietary supplement, vitamin, or health supplement within 2 weeks.
- 6. Drug abuse, excessive alcohol consumption, or excessive smoking, including:
- A history of drug abuse or a positive urine drug screen at screening;
- Average alcohol consumption of more than 14 units per week within 3 months before screening, a positive alcohol breath test at screening, or inability to abstain completely from alcohol-containing food or beverages during the study;
- Average smoking of more than 5 cigarettes per day within 3 months before screening, or inability to abstain from tobacco products during the study.
- 7. Blood donation, including component donation, or blood loss ≥400 mL within 3 months before screening; blood donation or blood loss ≥200 mL or receipt of a blood transfusion within 1 month before screening; or planned donation of blood or blood components during the study or within 1 month after study completion.
- 8. Difficulty with blood collection, inability to tolerate repeated venipuncture, or a clinically significant history of needle or blood phobia as judged by the investigator.
- 9. Dysphagia or special dietary requirements that prevent compliance with the standardized diet required by the study.
- 10. Receipt of a live vaccine, live attenuated vaccine, or any vaccine containing live viral components within 3 months before screening, or planned receipt of such a vaccine during the study or within 1 month after study completion.
- 11. Severe trauma or major surgery requiring general anesthesia within 3 months before screening, or planned surgery during the study or within 3 months after study completion, except procedures performed under local anesthesia.
- 12. Participation within 3 months before screening in, or current participation in, any interventional clinical study involving administration of an investigational drug or vaccine, including another clinical study of SAL0195 or another cohort of this study.
- 13. Any clinically significant disease, medical history, infectious disease, or other condition that, in the investigator's judgment, could interfere with completion of the study or significantly alter drug absorption, metabolism, or elimination, including clinically significant respiratory, cardiovascular, gastrointestinal, genitourinary, hematologic, endocrine, neurologic, psychiatric, or malignant disease, or relevant gastrointestinal, renal, or gallbladder surgery.
- 14. Poor compliance or any other factor that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
About this study
This is a randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of SAL0195 injection in participants with or without elevated lipoprotein(a) [Lp(a)]. Approximately 40 male and female participants aged 18 to 65 years will be enrolled across five planned dose cohorts. Participants will receive a single subcutaneous dose of SAL0195 or matching placebo.
Read the detailed description
This Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of a single subcutaneous dose of SAL0195 injection in participants with or without elevated lipoprotein(a) [Lp(a)]. The relationship between SAL0195 plasma concentrations and QTc will also be explored, and metabolites in blood and urine will be characterized in selected dose cohorts.
The study uses a randomized, double-blind, placebo-controlled, sequential single-ascending-dose design. Five dose levels are planned: 30 mg, 100 mg, 300 mg, 600 mg, and an optional 900 mg dose. Each dose cohort will enroll approximately 8 participants randomized in a 3:1 ratio to SAL0195 or placebo.
In the 30 mg cohort, approximately 4 participants without elevated Lp(a) and 4 participants with elevated Lp(a) will be enrolled. Randomization will be stratified by Lp(a) status, with participants within each stratum randomized in a 3:1 ratio to SAL0195 or placebo. The remaining dose cohorts will enroll participants with elevated Lp(a) and will use block randomization in a 3:1 ratio.
Each participant will receive only one dose level. Dose escalation will proceed sequentially from the lowest dose after review of available safety, tolerability, pharmacokinetic, and pharmacodynamic data from the preceding cohort. Participants will be followed through Day 85. Participants whose Lp(a) level remains below 60% of baseline at Day 85 will enter an extended follow-up period with visits every 28 days until Lp(a) returns to at least 60% of baseline, the participant reaches approximately 52 weeks after dosing, or the participant withdraws or is lost to follow-up, whichever occurs first.
- Conditions
- Elevated Lipoprotein(a)
- Being tested
- SAL0195 Injection 30 mg, SAL0195 Injection 100 mg, SAL0195 Injection 300 mg, SAL0195 Injection 600 mg, SAL0195 Injection 900 mg
- Keywords
- SAL0195, Lipoprotein(a), Elevated Lipoprotein(a), GalNAc-siRNA, Small Interfering RNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAL0195 Injection 30 mgDrug
A single 30 mg dose of SAL0195 injection will be administered subcutaneously on Day 1. SAL0195 injection is supplied at a concentration of 200 mg/mL. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites.
SAL0195 Injection 100 mgDrug
A single 100 mg dose of SAL0195 injection will be administered subcutaneously on Day 1. SAL0195 injection is supplied at a concentration of 200 mg/mL. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites.
SAL0195 Injection 300 mgDrug
A single 300 mg dose of SAL0195 injection will be administered subcutaneously on Day 1. SAL0195 injection is supplied at a concentration of 200 mg/mL. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites.
SAL0195 Injection 600 mgDrug
A single 600 mg dose of SAL0195 injection will be administered subcutaneously on Day 1. SAL0195 injection is supplied at a concentration of 200 mg/mL. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites.
SAL0195 Injection 900 mgDrug
A single 900 mg dose of SAL0195 injection will be administered subcutaneously on Day 1. SAL0195 injection is supplied at a concentration of 200 mg/mL. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites. This dose cohort is optional and may be initiated based on review of available safety, tolerability, pharmacokinetic, and pharmacodynamic data.
SAL0195 Matching PlaceboDrug
A single dose of matching placebo will be administered subcutaneously on Day 1. The placebo is matched to SAL0195 injection in appearance, odor, packaging, and administration characteristics but contains no active SAL0195. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites.
| Study group | Role | What they receive |
|---|---|---|
| SAL0195 30 mg | Experimental | Participants will receive a single 30 mg dose of SAL0195 injection administered subcutaneously on Day 1. The 30 mg cohort includes participants with and without elevated lipoprotein(a) [Lp(a)], with randomization stratified by baseline Lp(a) status. Receives: Drug: SAL0195 Injection 30 mg |
| Placebo - 30 mg Cohort | Placebo comparator | Participants will receive a single subcutaneous dose of matching placebo on Day 1 according to the administration procedure for the 30 mg cohort. The cohort includes participants with and without elevated Lp(a). Receives: Drug: SAL0195 Matching Placebo |
| SAL0195 100 mg | Experimental | Participants with elevated Lp(a) will receive a single 100 mg dose of SAL0195 injection administered subcutaneously on Day 1. Receives: Drug: SAL0195 Injection 100 mg |
| Placebo - 100 mg Cohort | Placebo comparator | Participants with elevated Lp(a) will receive a single subcutaneous dose of matching placebo on Day 1 according to the administration procedure for the 100 mg cohort. Receives: Drug: SAL0195 Matching Placebo |
| SAL0195 300 mg | Experimental | Participants with elevated Lp(a) will receive a single 300 mg dose of SAL0195 injection administered subcutaneously on Day 1. Receives: Drug: SAL0195 Injection 300 mg |
| Placebo - 300 mg Cohort | Placebo comparator | Participants with elevated Lp(a) will receive a single subcutaneous dose of matching placebo on Day 1 according to the administration procedure for the 300 mg cohort. Receives: Drug: SAL0195 Matching Placebo |
| SAL0195 600 mg | Experimental | Participants with elevated Lp(a) will receive a single 600 mg dose of SAL0195 injection administered subcutaneously on Day 1. Receives: Drug: SAL0195 Injection 600 mg |
| Placebo - 600 mg Cohort | Placebo comparator | Participants with elevated Lp(a) will receive a single subcutaneous dose of matching placebo on Day 1 according to the administration procedure for the 600 mg cohort. Receives: Drug: SAL0195 Matching Placebo |
| SAL0195 900 mg | Experimental | Participants with elevated Lp(a) will receive a single 900 mg dose of SAL0195 injection administered subcutaneously on Day 1. This dose cohort is optional and may be initiated based on review of available safety, tolerability, pharmacokinetic, and pharmacodynamic data. Receives: Drug: SAL0195 Injection 900 mg |
| Placebo - 900 mg Cohort | Placebo comparator | Participants with elevated Lp(a) will receive a single subcutaneous dose of matching placebo on Day 1 according to the administration procedure for the optional 900 mg cohort. Receives: Drug: SAL0195 Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs will include respiratory rate, body temperature, pulse rate, and systolic and diastolic blood pressure. Clinically significant abnormalities or worsening from baseline will be summarized by treatment and dose cohort.
Measured: From baseline through the end of the study, up to Day 365 after dosing.
Incidence and Severity of Treatment-Emergent Adverse Events
The number and percentage of participants with treatment-emergent adverse events (TEAEs), treatment-related adverse events, serious adverse events (SAEs), treatment-related serious adverse events, and adverse events leading to study discontinuation will be summarized by treatment and dose cohort. Adverse events will be assessed for severity and relationship to the study intervention.
Measured: From study drug administration through the end of the study, up to Day 365 after dosing.
Number of Participants With Clinically Significant Physical Examination Abnormalities
Physical examinations will include assessments of the skin and mucous membranes, superficial lymph nodes, head, neck, chest, abdomen, spine and extremities, nervous system, and other clinically relevant findings. Clinically significant abnormalities or worsening from baseline will be summarized.
Measured: From baseline through the end of the study, up to Day 365 after dosing.
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Clinical laboratory evaluations will include hematology, serum chemistry, urinalysis, and coagulation tests. Clinically significant post-baseline abnormalities or worsening from baseline will be summarized by treatment and dose cohort.
Measured: From baseline through the end of the study, up to Day 365 after dosing.
Number of Participants With Clinically Significant Twelve-Lead Electrocardiogram Abnormalities
Twelve-lead electrocardiograms will be evaluated for clinically significant abnormalities and changes from baseline. Findings will be summarized by treatment and dose cohort.
Measured: From baseline through the end of the study, up to Day 365 after dosing.
Incidence and Severity of Injection-Site Reactions
Injection-site reactions, including local signs and symptoms such as erythema, induration, pain, pruritus, and swelling, will be assessed following subcutaneous administration of SAL0195 or matching placebo.
Measured: From pre-dose through 72 hours after dosing.
Secondary outcomes (9)
Maximum Observed Plasma Concentration of SAL0195 (Cmax)
Maximum observed plasma concentration (Cmax) of SAL0195 following a single subcutaneous dose of SAL0195 injection.
Measured: Pre-dose through 72 hours after dosing.
Time to Maximum Observed Plasma Concentration of SAL0195 (Tmax)
Time to reach the maximum observed plasma concentration of SAL0195.
Measured: Pre-dose through 72 hours after dosing.
Area Under the Plasma Concentration-Time Curve to the Last Quantifiable Concentration (AUClast)
Area under the plasma concentration-time curve of SAL0195 from time zero to the last quantifiable concentration.
Measured: Pre-dose through 72 hours after dosing.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf)
Area under the plasma concentration-time curve of SAL0195 from time zero extrapolated to infinity.
Measured: Pre-dose through 72 hours after dosing.
Percentage of AUC Extrapolated to Infinity (AUC_%Extrap)
Percentage of the total AUC extrapolated from the last quantifiable concentration to infinity.
Measured: Pre-dose through 72 hours after dosing.
Terminal Elimination Half-Life of SAL0195 (t1/2)
Terminal elimination half-life of SAL0195 following a single subcutaneous dose.
Measured: Pre-dose through 72 hours after dosing.
Terminal Elimination Rate Constant of SAL0195 (λz)
Terminal elimination rate constant of SAL0195 estimated from the terminal phase of the plasma concentration-time profile.
Measured: Pre-dose through 72 hours after dosing.
Apparent Total Clearance of SAL0195 (CL/F)
Apparent total clearance of SAL0195 following subcutaneous administration.
Measured: Pre-dose through 72 hours after dosing.
Apparent Volume of Distribution of SAL0195 (Vz/F)
Apparent volume of distribution of SAL0195 during the terminal phase following subcutaneous administration.
Measured: Pre-dose through 72 hours after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start30 Aug 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Lipoprotein(a)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Responsible party
- Principal investigator, Guoping Yang, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804160
- Sponsor's protocol ID
- SAL0195A101
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0195 Injection in Participants With or Without Elevated Lipoprotein(a)
- ClinicalTrials.gov ID
- NCT07804160
- Acronym / sponsor ID
- SAL0195A101
- Conditions
- Elevated Lipoprotein(a)
- Keywords
- SAL0195, Lipoprotein(a), Elevated Lipoprotein(a), GalNAc-siRNA, Small Interfering RNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of SAL0195 injection in participants with or without elevated lipoprotein(a) [Lp(a)]. Approximately 40 male and female participants aged 18 to 65 years will be enrolled across five planned dose cohorts. Participants will receive a single subcutaneous dose of SAL0195 or matching placebo.
Detailed description
This Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of a single subcutaneous dose of SAL0195 injection in participants with or without elevated lipoprotein(a) [Lp(a)]. The relationship between SAL0195 plasma concentrations and QTc will also be explored, and metabolites in blood and urine will be characterized in selected dose cohorts.
The study uses a randomized, double-blind, placebo-controlled, sequential single-ascending-dose design. Five dose levels are planned: 30 mg, 100 mg, 300 mg, 600 mg, and an optional 900 mg dose. Each dose cohort will enroll approximately 8 participants randomized in a 3:1 ratio to SAL0195 or placebo.
In the 30 mg cohort, approximately 4 participants without elevated Lp(a) and 4 participants with elevated Lp(a) will be enrolled. Randomization will be stratified by Lp(a) status, with participants within each stratum randomized in a 3:1 ratio to SAL0195 or placebo. The remaining dose cohorts will enroll participants with elevated Lp(a) and will use block randomization in a 3:1 ratio.
Each participant will receive only one dose level. Dose escalation will proceed sequentially from the lowest dose after review of available safety, tolerability, pharmacokinetic, and pharmacodynamic data from the preceding cohort. Participants will be followed through Day 85. Participants whose Lp(a) level remains below 60% of baseline at Day 85 will enter an extended follow-up period with visits every 28 days until Lp(a) returns to at least 60% of baseline, the participant reaches approximately 52 weeks after dosing, or the participant withdraws or is lost to follow-up, whichever occurs first.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| SAL0195 30 mg | Experimental | Drug: SAL0195 Injection 30 mgParticipants will receive a single 30 mg dose of SAL0195 injection administered subcutaneously on Day 1. The 30 mg cohort includes participants with and without elevated lipoprotein(a) [Lp(a)], with randomization stratified by baseline Lp(a) status. |
| Placebo - 30 mg Cohort | Placebo comparator | Drug: SAL0195 Matching PlaceboParticipants will receive a single subcutaneous dose of matching placebo on Day 1 according to the administration procedure for the 30 mg cohort. The cohort includes participants with and without elevated Lp(a). |
| SAL0195 100 mg | Experimental | Drug: SAL0195 Injection 100 mgParticipants with elevated Lp(a) will receive a single 100 mg dose of SAL0195 injection administered subcutaneously on Day 1. |
| Placebo - 100 mg Cohort | Placebo comparator | Drug: SAL0195 Matching PlaceboParticipants with elevated Lp(a) will receive a single subcutaneous dose of matching placebo on Day 1 according to the administration procedure for the 100 mg cohort. |
| SAL0195 300 mg | Experimental | Drug: SAL0195 Injection 300 mgParticipants with elevated Lp(a) will receive a single 300 mg dose of SAL0195 injection administered subcutaneously on Day 1. |
| Placebo - 300 mg Cohort | Placebo comparator | Drug: SAL0195 Matching PlaceboParticipants with elevated Lp(a) will receive a single subcutaneous dose of matching placebo on Day 1 according to the administration procedure for the 300 mg cohort. |
| SAL0195 600 mg | Experimental | Drug: SAL0195 Injection 600 mgParticipants with elevated Lp(a) will receive a single 600 mg dose of SAL0195 injection administered subcutaneously on Day 1. |
| Placebo - 600 mg Cohort | Placebo comparator | Drug: SAL0195 Matching PlaceboParticipants with elevated Lp(a) will receive a single subcutaneous dose of matching placebo on Day 1 according to the administration procedure for the 600 mg cohort. |
| SAL0195 900 mg | Experimental | Drug: SAL0195 Injection 900 mgParticipants with elevated Lp(a) will receive a single 900 mg dose of SAL0195 injection administered subcutaneously on Day 1. This dose cohort is optional and may be initiated based on review of available safety, tolerability, pharmacokinetic, and pharmacodynamic data. |
| Placebo - 900 mg Cohort | Placebo comparator | Drug: SAL0195 Matching PlaceboParticipants with elevated Lp(a) will receive a single subcutaneous dose of matching placebo on Day 1 according to the administration procedure for the optional 900 mg cohort. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Participants who have fully understood the study, voluntarily provided written informed consent, and are able to comply with the requirements and restrictions specified in the informed consent form.
- 2. Male or female participants aged 18 to 65 years, inclusive.
- 3. At screening, male participants must weigh at least 50 kg and female participants must weigh at least 45 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m², inclusive.
- 4. For participants required to have elevated lipoprotein(a) [Lp(a)], screening Lp(a) must be ≥75 nmol/L or ≥30 mg/dL. The 30 mg dose cohort may include participants with or without elevated Lp(a), as specified in the protocol.
- 5. At screening, physical examination, vital signs, hematology, urinalysis, serum chemistry, coagulation tests, viral serology, and glycated hemoglobin results, except for Lp(a), must be normal or show only minor abnormalities considered not clinically significant by the investigator. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must not exceed the upper limit of normal.
Key exclusion criteria (20 listed)
- 1. Women who are pregnant or breastfeeding; women of childbearing potential with a positive pregnancy test; or women of childbearing potential who have had unprotected sexual intercourse within 14 days before the first dose.
- 2. Any disease or medical history considered by the investigator to alter or increase bleeding tendency, including but not limited to acute gastritis, gastrointestinal ulcer, allergic purpura, systemic lupus erythematosus, previous intracranial or intraocular hemorrhage, hemophilia, or von Willebrand disease.
- 3. A clinically significant acute drug or food allergic reaction within 2 weeks before screening; an allergic constitution, such as allergy to two or more drugs, foods, or pollens; a history of allergic disease such as asthma, urticaria, or eczematous dermatitis; or known or suspected hypersensitivity or clinically significant reaction to the study intervention, related drugs, placebo, or any excipient.
- 4. Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum-specific antibody.
- Administration of a small interfering RNA (siRNA) or antisense oligonucleotide within 18 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAL0195 Injection 30 mgA single 30 mg dose of SAL0195 injection will be administered subcutaneously on Day 1. SAL0195 injection is supplied at a concentration of 200 mg/mL. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites. | Drug | SAL0195 30 mg |
| SAL0195 Injection 100 mgA single 100 mg dose of SAL0195 injection will be administered subcutaneously on Day 1. SAL0195 injection is supplied at a concentration of 200 mg/mL. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites. | Drug | SAL0195 100 mg |
| SAL0195 Injection 300 mgA single 300 mg dose of SAL0195 injection will be administered subcutaneously on Day 1. SAL0195 injection is supplied at a concentration of 200 mg/mL. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites. | Drug | SAL0195 300 mg |
| SAL0195 Injection 600 mgA single 600 mg dose of SAL0195 injection will be administered subcutaneously on Day 1. SAL0195 injection is supplied at a concentration of 200 mg/mL. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites. | Drug | SAL0195 600 mg |
| SAL0195 Injection 900 mgA single 900 mg dose of SAL0195 injection will be administered subcutaneously on Day 1. SAL0195 injection is supplied at a concentration of 200 mg/mL. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites. This dose cohort is optional and may be initiated based on review of available safety, tolerability, pharmacokinetic, and pharmacodynamic data. | Drug | SAL0195 900 mg |
| SAL0195 Matching PlaceboA single dose of matching placebo will be administered subcutaneously on Day 1. The placebo is matched to SAL0195 injection in appearance, odor, packaging, and administration characteristics but contains no active SAL0195. The preferred injection site is the abdomen, with the upper arm or thigh as alternative injection sites. | Drug | Placebo - 100 mg Cohort, Placebo - 30 mg Cohort, Placebo - 300 mg Cohort, Placebo - 600 mg Cohort, Placebo - 900 mg Cohort |
Primary outcome
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: From baseline through the end of the study, up to Day 365 after dosing.
Vital signs will include respiratory rate, body temperature, pulse rate, and systolic and diastolic blood pressure. Clinically significant abnormalities or worsening from baseline will be summarized by treatment and dose cohort.
Incidence and Severity of Treatment-Emergent Adverse Events
Time frame: From study drug administration through the end of the study, up to Day 365 after dosing.
The number and percentage of participants with treatment-emergent adverse events (TEAEs), treatment-related adverse events, serious adverse events (SAEs), treatment-related serious adverse events, and adverse events leading to study discontinuation will be summarized by treatment and dose cohort. Adverse events will be assessed for severity and relationship to the study intervention.
Number of Participants With Clinically Significant Physical Examination Abnormalities
Time frame: From baseline through the end of the study, up to Day 365 after dosing.
Physical examinations will include assessments of the skin and mucous membranes, superficial lymph nodes, head, neck, chest, abdomen, spine and extremities, nervous system, and other clinically relevant findings. Clinically significant abnormalities or worsening from baseline will be summarized.
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Time frame: From baseline through the end of the study, up to Day 365 after dosing.
Clinical laboratory evaluations will include hematology, serum chemistry, urinalysis, and coagulation tests. Clinically significant post-baseline abnormalities or worsening from baseline will be summarized by treatment and dose cohort.
Number of Participants With Clinically Significant Twelve-Lead Electrocardiogram Abnormalities
Time frame: From baseline through the end of the study, up to Day 365 after dosing.
Twelve-lead electrocardiograms will be evaluated for clinically significant abnormalities and changes from baseline. Findings will be summarized by treatment and dose cohort.
Incidence and Severity of Injection-Site Reactions
Time frame: From pre-dose through 72 hours after dosing.
Injection-site reactions, including local signs and symptoms such as erythema, induration, pain, pruritus, and swelling, will be assessed following subcutaneous administration of SAL0195 or matching placebo.
9 secondary outcomes
Maximum Observed Plasma Concentration of SAL0195 (Cmax)
Time frame: Pre-dose through 72 hours after dosing.
Time to Maximum Observed Plasma Concentration of SAL0195 (Tmax)
Time frame: Pre-dose through 72 hours after dosing.
Area Under the Plasma Concentration-Time Curve to the Last Quantifiable Concentration (AUClast)
Time frame: Pre-dose through 72 hours after dosing.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf)
Time frame: Pre-dose through 72 hours after dosing.
Percentage of AUC Extrapolated to Infinity (AUC_%Extrap)
Time frame: Pre-dose through 72 hours after dosing.
Terminal Elimination Half-Life of SAL0195 (t1/2)
Time frame: Pre-dose through 72 hours after dosing.
Terminal Elimination Rate Constant of SAL0195 (λz)
Time frame: Pre-dose through 72 hours after dosing.
Apparent Total Clearance of SAL0195 (CL/F)
Time frame: Pre-dose through 72 hours after dosing.
Apparent Volume of Distribution of SAL0195 (Vz/F)
Time frame: Pre-dose through 72 hours after dosing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAL0195 Injection 30 mg, SAL0195 Injection 100 mg and SAL0195 Injection 300 mg in people with Elevated Lipoprotein(a), run by The Third Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinically Significant Changes in Vital Signs (time frame: From baseline through the end of the study, up to Day 365 after dosing.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.