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

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of BSA204 Injection in Chinese Adults With Borderline Elevated Lipoprotein(a)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07551505

Enrollment

Registered

2026-04-24

Start date

2026-04-20

Completion date

2027-12-31

Last updated

2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias

Brief 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) \[Lp(a)\].

Detailed 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.

Interventions

DRUGBSA204

BSA204 Injection

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)	From the time of dosing on Day 1 through Day180

Secondary

Measure	Time frame
Percent change from Baseline in serum LDL-C and Lp(a) at Day 180	From the time of dosing on Day 1 through Day 180

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026