A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0195 Injection in Participants With or Without Elevated Lipoprotein(a)

NCT07804160 | Not Yet Recruiting Phase 1

• 1 other identifier: SAL0195A101
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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) \[Lp(a)\]. 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.

Conditions

Elevated Lipoprotein(a)

Keywords

SAL0195; Lipoprotein(a); Elevated Lipoprotein(a); GalNAc-siRNA; Small Interfering RNA

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  From pre-dose through 72 hours after dosing.

Secondary Outcomes (9)

• Maximum Observed Plasma Concentration of SAL0195 (Cmax)

  Pre-dose through 72 hours after dosing.

• Time to Maximum Observed Plasma Concentration of SAL0195 (Tmax)

  Pre-dose through 72 hours after dosing.

• Area Under the Plasma Concentration-Time Curve to the Last Quantifiable Concentration (AUClast)

  Pre-dose through 72 hours after dosing.

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf)

  Pre-dose through 72 hours after dosing.

• Percentage of AUC Extrapolated to Infinity (AUC_%Extrap)

  Pre-dose through 72 hours after dosing.

Study Arms (10)

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

Drug: SAL0195 Matching Placebo

Interventions

SAL0195 Injection 30 mg DRUG

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 30 mg

SAL0195 Injection 100 mg DRUG

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 100 mg

SAL0195 Injection 600 mg DRUG

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 600 mg

SAL0195 Matching Placebo DRUG

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.

Placebo - 100 mg Cohort; Placebo - 30 mg Cohort; Placebo - 300 mg Cohort; Placebo - 600 mg Cohort; Placebo - 900 mg Cohort

SAL0195 Injection 300 mg DRUG

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 300 mg

SAL0195 Injection 900 mg DRUG

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 900 mg

Eligibility Criteria

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

You may qualify if:

• \. 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.
• \. Male or female participants aged 18 to 65 years, inclusive.
• \. 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.
• \. 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.
• \. 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.
• \. Twelve-lead electrocardiogram findings must be normal or considered not clinically significant by the investigator, with QTcF \<450 ms.
• \. 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum-specific antibody.
• \. Any of the following prior to the first dose:
• Administration of a small interfering RNA (siRNA) or antisense oligonucleotide within 18 months;
• 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.
• \. 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.
• \. 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.
• \. Difficulty with blood collection, inability to tolerate repeated venipuncture, or a clinically significant history of needle or blood phobia as judged by the investigator.
• \. Dysphagia or special dietary requirements that prevent compliance with the standardized diet required by the study.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• Shenzhen Salubris Pharmaceuticals Co., Ltd.: collaborator

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacology

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-08