About this trial
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) \[Lp(a)\].
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- BSA204
- Placebo