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

August 18, 2026 updated by: Bisirna Therapeutics (Suzhou) Co., Ltd.

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)

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)].

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort1
Drug: Placebo
Placebo
Drug: BSA204
BSA204 Injection
Experimental: Cohort2
Drug: Placebo
Placebo
Drug: BSA204
BSA204 Injection
Experimental: Cohort3
Drug: Placebo
Placebo
Drug: BSA204
BSA204 Injection
Experimental: Cohort4
Drug: Placebo
Placebo
Drug: BSA204
BSA204 Injection
Experimental: Cohort5
Drug: Placebo
Placebo
Drug: BSA204
BSA204 Injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From the time of dosing on Day 1 through Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bisirna Therapeutics (Suzhou) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 19, 2026

First Submitted That Met QC Criteria

April 19, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSA204-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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