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Not yet recruiting NCT07551505

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

Phase I Interventional Dyslipidemias

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BSA204, Placebo.
Who it may be relevant to
Registry conditions: Dyslipidemias. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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

  • Drug BSA204
    BSA204 Injection
  • Drug Placebo
    Placebo

Primary outcome measures

  • Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: From the time of dosing on Day 1 through Day180]
Secondary outcome measures (1)
  • Percent change from Baseline in serum LDL-C and Lp(a) at Day 180 [Time frame: From the time of dosing on Day 1 through Day 180]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Peking University First Hospital — Beijing
  • Peking University First Hospital — Beijing

Identifiers

NCT: NCT07551505 · BSA204-1001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗