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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the time of dosing on Day 1 through Day180
Percent change from Baseline in serum LDL-C and Lp(a) at Day 180
Time frame: From the time of dosing on Day 1 through Day 180
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