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.
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.
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.
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.
Sequential
SAL0195 Injection 30 mg
DrugA 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 mg
DrugA 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 mg
DrugA 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 mg
DrugA 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 mg
DrugA 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 Placebo
DrugA 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.
10
Treatment groupsSee each treatment group below.
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.
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.
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.
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.
Maximum Observed Plasma Concentration of SAL0195 (Cmax)
Maximum observed plasma concentration (Cmax) of SAL0195 following a single subcutaneous dose of SAL0195 injection.
Time to Maximum Observed Plasma Concentration of SAL0195 (Tmax)
Time to reach the maximum observed plasma concentration of SAL0195.
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.
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.
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The Third Xiangya Hospital of Central South University
Lead sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Collaborator
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