Safety, PK, and PD of BSA204 in Chinese Adults With Borde... | NCT07551505

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

NCT07551505

Sponsor

Bisirna Therapeutics (Suzhou) Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Apr 28, 2026Actual

Enrollment

40Estimated

Phase

Phase 1

Conditions

Dyslipidemias

Interventions

BSA204
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2026Estimated

Primary Completion Date

Jul 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Apr 19, 2026

First Submission Date that Met QC Criteria

Apr 19, 2026

First Posted Date

Apr 24, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2026

Last Update Posted Date

Apr 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Cohort1	Experimental	Drug: BSA204 Drug: Placebo
Cohort2	Experimental	Drug: BSA204 Drug: Placebo
Cohort3	Experimental	Drug: BSA204 Drug: Placebo
Cohort4	Experimental	Drug: BSA204 Drug: Placebo
Cohort5	Experimental	Drug: BSA204 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BSA204	Drug	BSA204 Injection	Cohort1 Cohort2 Cohort3 Cohort4 Cohort5

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Charlene Si	Contact	13816432852		charlene.si@bisirna.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital		Beijing	Beijing Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided