Safety, PK, and PD of BSA204 in Chinese Adults With Borderline Elevated Lipoprotein(a)

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of BSA204 Injection in Chinese Adults With Borderline Elevated Lipoprotein(a)

The purpose of this Phase 1 clinical study is to evaluate the safety and tolerability of a single dose of BSA204 injection in Chinese adults with borderline high levels of lipoprotein(a) [Lp(a)].

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study conducted in Chinese adult participants with borderline elevated lipoprotein(a) [Lp(a)]. The study aims to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of BSA204.

Inclusion Criteria:

• Body mass index (BMI) 18 to 30 kg/m2
• Fasting triglycerides (TG) ≤ 4.5 mmol/L
• Borderline elevated fasting lipoprotein(a) [Lp(a)] levels as defined in the protocol
• Fasting low-density lipoprotein cholesterol (LDL-C) within the range specified for the assigned dose cohort
• o clinically significant abnormalities of hepatic or renal function

Exclusion Criteria:

• Pregnant or lactating women.
• History or presence of significant medical conditions
• Abnormal ECG findings, including a prolonged QTcF interval (> 450 msec for males or > 470 msec for females)
• Prior treatment with small interfering RNA (siRNA) or antisense oligonucleotides within 12 months, or recent use of specific lipid-lowering therapies
• Known allergy to any component of the study drug