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
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) — From the time of dosing on Day 1 through Day180
Trial sites (1)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
More Bisirna Therapeutics (Suzhou) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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