DyslipidemiasPhase 1NCT07551505
Safety, PK, and PD of BSA204 in Chinese Adults With Borderline Elevated Lipoprotein(a)
A Phase 1 study testing BSA204 in people with Dyslipidemias, run by Bisirna Therapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial 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)]. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- BSA204
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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)].
Read the 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.
- Conditions
- Dyslipidemias
- Being tested
- BSA204, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSA204Drug
BSA204 Injection
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Experimental | Not described Receives: Drug: BSA204; Drug: Placebo |
| Cohort2 | Experimental | Not described Receives: Drug: BSA204; Drug: Placebo |
| Cohort3 | Experimental | Not described Receives: Drug: BSA204; Drug: Placebo |
| Cohort4 | Experimental | Not described Receives: Drug: BSA204; Drug: Placebo |
| Cohort5 | Experimental | Not described Receives: Drug: BSA204; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 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
Measured: From the time of dosing on Day 1 through Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start20 Apr 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bisirna Therapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551505
- Sponsor's protocol ID
- BSA204-1001
- Status last verified
- Aug 2026
- First submitted
- 19 Apr 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07551505
- Acronym / sponsor ID
- BSA204-1001
- Conditions
- Dyslipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bisirna Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BSA204BSA204 Injection | Drug | Cohort1, Cohort2, Cohort3, Cohort4, Cohort5 |
| PlaceboPlacebo | Drug | Cohort1, Cohort2, Cohort3, Cohort4, Cohort5 |
Primary outcome
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the time of dosing on Day 1 through Day180
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Dyslipidemias
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BSA204 in people with Dyslipidemias, run by Bisirna Therapeutics (Suzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From the time of dosing on Day 1 through Day180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.