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

This Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics,immunogenicity, and pharmacodynamics of a single subcutaneous dose of SAL0195 injectionin participants with or without elevated lipoprotein(a) [Lp(a)]. The relationship betweenSAL0195 plasma concentrations and QTc will also be explored, and metabolites in blood andurine will be characterized in selected dose cohorts.The study uses a randomized, double‐blind, placebo‐controlled, sequentialsingle‐ascending‐dose design. Five dose levels are planned: 30 mg, 100 mg, 300 mg, 600mg, and an optional 900 mg dose. Each dose cohort will enroll approximately 8participants randomized in a 3:1 ratio to SAL0195 or placebo.In the 30 mg cohort, approximately 4 participants without elevated Lp(a) and 4participants with elevated Lp(a) will be enrolled. Randomization will be stratified byLp(a) status, with participants within each stratum randomized in a 3:1 ratio to SAL0195or placebo. The remaining dose cohorts will enroll participants with elevated Lp(a) andwill use block randomization in a 3:1 ratio.Each participant will receive only one dose level. Dose escalation will proceedsequentially from the lowest dose after review of available safety, tolerability,pharmacokinetic, and pharmacodynamic data from the preceding cohort. Participants will befollowed through Day 85. Participants whose Lp(a) level remains below 60% of baseline atDay 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 afterdosing, or the participant withdraws or is lost to follow‐up, whichever occurs first.