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)
1 other identifier
interventional
40
1 country
2
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) \[Lp(a)\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2026
CompletedStudy Start
First participant enrolled
April 20, 2026
CompletedFirst Posted
Study publicly available on registry
April 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 28, 2026
April 1, 2026
1.3 years
April 19, 2026
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
From the time of dosing on Day 1 through Day180
Secondary Outcomes (1)
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
Study Arms (5)
Cohort1
EXPERIMENTALCohort2
EXPERIMENTALCohort3
EXPERIMENTALCohort4
EXPERIMENTALCohort5
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2026
First Posted
April 24, 2026
Study Start
April 20, 2026
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share