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A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAL0195 Injection in Participants With or Without Elevated Lipoprotein(a)
Sponsor: The Third Xiangya Hospital of Central South University
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-08-30
Completion Date
2027-08-31
Last Updated
2026-09-04
Healthy Volunteers
Yes
Conditions
Interventions
SAL0195 Injection 30 mg
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 mg
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 mg
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 mg
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 mg
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 Placebo
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.