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Clinical Trials in China / NCT07551505
Active, not recruiting Phase 1

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

NCT07551505 · tracked via the Priya Life Science China tracker
Sponsor
Bisirna Therapeutics (Suzhou) Co., Ltd
Phase
Phase 1
Started
2026-04-20
Last updated
2026-08-19

Condition(s) studied

Dyslipidemias

Investigational drug(s) / intervention(s)

BSA204Placebo

BSA204: BSA204 Injection

Placebo: Placebo

Study 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

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)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality

More Bisirna Therapeutics (Suzhou) Co., Ltd. trials in China

A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy Starting soon
A Phase I Clinical Study of VSA012 in Healthy Volunteers Active, not recruiting

Other trials for the same condition

Retinal Vascular Manifestations in Patients With Common Internal Diseases on OCTA Tomography Angiography Recruiting
Accuracy Assessment of a Novel Gas Detection Approach in Dyslipidemia Diagnosis Starting soon
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia Recruiting
Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus Active, not recruiting
Official registry record

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.

View NCT07551505 on ClinicalTrials.gov ↗ ← All trials in China