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

Sex: All

Ages: 18 Years – 55 Years

Healthy volunteers: Yes

Phase: PHASE1

Enrollment: 40

Sponsor: Bisirna Therapeutics (Suzhou) Co., Ltd.

Summary

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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07551505). StuddyBuddy aggregates publicly available trial information.