DyslipidemiasPhase 1NCT05851066
A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers
A Phase 1 study testing VSA003 and 0.9% NaCl in people with Dyslipidemias and Familial Hypercholesterolemia, run by Visirna Therapeutics HK Limited at 1 site in China.
Trial summary
This is a randomized, double blinded, phase 1 study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of VSA003 in healthy adult volunteerst Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia
- What is being tested?
- VSA003 and 0.9% NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 7 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
- BMI 18.0~28.0 kg/m2
- Willing to provide written informed consent and to comply with study requirements
- On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
- TG> 100 mg/dL
- LDL-C> 70 mg/dL
Who cannot join
- Clinically significant health concerns
- Regular use of alcohol within one month prior to screening
- Recent (within 3 months) use of illicit drugs
- Female with pregnancy or breastfeeding
- QTcF>450 ms in ECG
- Donation or loss of whole blood more than 400 ml prior to administration of the study treatment
- Note: additional inclusion/exclusion criteria may apply, per protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of VSA003 in Chinese Adult Healthy Volunteers
This is a randomized, double blinded, phase 1 study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of VSA003 in healthy adult volunteerst
- Being tested
- VSA003, 0.9% NaCl
- Medical subject headings
- Dyslipidemias, Hyperlipoproteinemia Type II, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSA003Drug
sequential dosing, SC, single dose: 50 mg, 100 mg, 200 mg
0.9% NaClDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| VSA003 | Experimental | single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg Receives: Drug: VSA003 |
| placebo | Placebo comparator | sterile normal saline (0.9% NaCl) calculated volume to match active treatment Receives: Drug: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse event (AE) and serious adverse event (SAE)
safety and tolerability
Measured: Up to 85±3 days post-dose
Secondary outcomes (8)
Maximum observed concentration (Cmax) of VSA003
pharmacokinetics (PK)
Measured: Up to 48 hours post dose
Time of occurrence of Cmax (tmax) of VSA003
PK
Measured: Up to 48 hours post dose
Apparent terminal phase half-life (t1/2) of VSA003
PK
Measured: Up to 48 hours post dose
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA003
PK
Measured: Up to 48 hours post dose
Apparent clearance (CL/F) of VSA003
PK
Measured: Up to 48 hours post dose
Apparent terminal phase volume of distribution (Vz/F) of VSA003
PK
Measured: Up to 48 hours post dose
Change of fasting serum ANGPTL3 from pre-dose baseline
PD
Measured: Up to 85±3 days post-dose
Anti-drug Antibodies (ADA) to VSA003
immunogenecity
Measured: Up to 85±3 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Jun 2023
- Primary completion7 May 2024
- Study completion7 May 2024
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visirna Therapeutics HK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851066
- Sponsor's protocol ID
- VSA003-1001
- Status last verified
- Sep 2025
- First submitted
- 26 Apr 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of VSA003 in Chinese Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05851066
- Acronym / sponsor ID
- VSA003-1001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Visirna Therapeutics HK LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 9 May 2023 (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.
This is a randomized, double blinded, phase 1 study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of VSA003 in healthy adult volunteerst
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSA003 | Experimental | Drug: VSA003single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg |
| placebo | Placebo comparator | Drug: 0.9% NaClsterile normal saline (0.9% NaCl) calculated volume to match active treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
- BMI 18.0~28.0 kg/m2
- Willing to provide written informed consent and to comply with study requirements
- On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
- TG> 100 mg/dL
Key exclusion criteria (7 listed)
- Clinically significant health concerns
- Regular use of alcohol within one month prior to screening
- Recent (within 3 months) use of illicit drugs
- Female with pregnancy or breastfeeding
- QTcF>450 ms in ECG
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 |
|---|---|---|
| VSA003sequential dosing, SC, single dose: 50 mg, 100 mg, 200 mg | Drug | VSA003 |
| 0.9% NaClplacebo | Drug | placebo |
Primary outcome
Frequency and severity of adverse event (AE) and serious adverse event (SAE)
Time frame: Up to 85±3 days post-dose
safety and tolerability
8 secondary outcomes
Maximum observed concentration (Cmax) of VSA003
Time frame: Up to 48 hours post dose
Time of occurrence of Cmax (tmax) of VSA003
Time frame: Up to 48 hours post dose
Apparent terminal phase half-life (t1/2) of VSA003
Time frame: Up to 48 hours post dose
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA003
Time frame: Up to 48 hours post dose
Apparent clearance (CL/F) of VSA003
Time frame: Up to 48 hours post dose
Apparent terminal phase volume of distribution (Vz/F) of VSA003
Time frame: Up to 48 hours post dose
Change of fasting serum ANGPTL3 from pre-dose baseline
Time frame: Up to 85±3 days post-dose
Anti-drug Antibodies (ADA) to VSA003
Time frame: Up to 85±3 days post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Dyslipidemias
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
Dyslipidemia
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 VSA003 and 0.9% NaCl in people with Dyslipidemias and Familial Hypercholesterolemia, run by Visirna Therapeutics HK Limited 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 12 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency and severity of adverse event (AE) and serious adverse event (SAE) (time frame: Up to 85±3 days post-dose). 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 12 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.