Safety, PK, and PD of BSA204 in Chinese Adults With Borderline Elevated Lipoprotein(a)
Phase 1 – testing safety in a small group of people
Conditions:
Dyslipidemias
Sponsor: Bisirna Therapeutics (Suzhou) Co., Ltd.
trial.available_in:
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Overview
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) \[Lp(a)\].
Description
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.
Who can participate
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 No 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
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