Healthy VolunteersPhase 1NCT06766929
A Phase I Clinical Study of VSA012 in Healthy Volunteers
A Phase 1 study testing VSA012 in people with Healthy Volunteers, run by Bisirna Therapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
The complement system is an important component of the innate immune system. Abnormal activation, inadequate regulation and control of the complement system, as well as impaired and dysfunctional effector functions, underlie complement mediated diseases. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- VSA012
- 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 Jan 2025to Jun 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
- Willing to provide written informed consent and to comply with study requirements
- Participants must be non-pregnant/non-lactating
- Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine.
- Body Mass Index (BMI) between 18.0 and 30.0 kg/m2
- No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the Investigator, could adversely impact participant safety or adversely impact study results.
Who cannot join
- History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses
- History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations
- Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
- History of meningococcal infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VSA012 After Single Ascending Doses in Healthy Volunteers
The complement system is an important component of the innate immune system. Abnormal activation, inadequate regulation and control of the complement system, as well as impaired and dysfunctional effector functions, underlie complement mediated diseases. VSA012 targeting complement system has the potential to treat a variety of diseases associated with abnormal activation of the complement system (e.g. PNH) .The purpose of VSA012-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VSA012 Injection in adult healthy volunteers (HVs). HVs will receive a single dose of VSA012 or placebo.
- Conditions
- Healthy Volunteers
- Being tested
- VSA012, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSA012Drug
VSA012 injection
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Experimental | Not described Receives: Drug: VSA012; Drug: Placebo |
| Cohort2 | Experimental | Not described Receives: Drug: VSA012; Drug: Placebo |
| cohort3 | Experimental | Not described Receives: Drug: VSA012; Drug: Placebo |
| Cohort4 | Experimental | Not described Receives: Drug: VSA012; Drug: Placebo |
| cohort5 | Experimental | Not described Receives: Drug: VSA012; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Measured: up to Day 180
Secondary outcomes (6)
Pharmacokinetics (PK) of VSA012: Maximum Observed Plasma Concentration (Cmax)
Measured: Up to 48 hours post-dose
PK of VSA012: Time to Maximum Observed Plasma Concentration (Tmax)
Measured: Up to 48 hours post-dose
PK of VSA012: Area Under the Plasma Concentration Versus Time Curve
Measured: Up to 48 hours post-dose
Change from Baseline in Serum Complement Factor B (CFB)
Measured: Up to Day 180
Change from Baseline in Serum Complement Alternative Pathway (CAP)
Measured: up to Day 180
The incidence of ADA
Measured: up to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start20 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
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
- NCT06766929
- Sponsor's protocol ID
- VSA012-1001
- Status last verified
- Apr 2026
- First submitted
- 29 Dec 2024
- Last updated
- 4 May 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 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VSA012 After Single Ascending Doses in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06766929
- Acronym / sponsor ID
- VSA012-1001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bisirna Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Jan 2025 (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 complement system is an important component of the innate immune system. Abnormal activation, inadequate regulation and control of the complement system, as well as impaired and dysfunctional effector functions, underlie complement mediated diseases. VSA012 targeting complement system has the potential to treat a variety of diseases associated with abnormal activation of the complement system (e.g. PNH) .The purpose of VSA012-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VSA012 Injection in adult healthy volunteers (HVs). HVs will receive a single dose of VSA012 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort1 | Experimental | Drug: VSA012, Drug: Placebo |
| Cohort2 | Experimental | Drug: VSA012, Drug: Placebo |
| cohort3 | Experimental | Drug: VSA012, Drug: Placebo |
| Cohort4 | Experimental | Drug: VSA012, Drug: Placebo |
| cohort5 | Experimental | Drug: VSA012, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing to provide written informed consent and to comply with study requirements
- Participants must be non-pregnant/non-lactating
- Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine.
- Body Mass Index (BMI) between 18.0 and 30.0 kg/m2
- No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the Investigator, could adversely impact participant safety or adversely impact study results.
Key exclusion criteria (4 listed)
- History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses
- History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations
- Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
- History of meningococcal infection
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 |
|---|---|---|
| VSA012VSA012 injection | Drug | Cohort1, Cohort2, Cohort4, cohort3, cohort5 |
| PlaceboPlacebo | Drug | Cohort1, Cohort2, Cohort4, cohort3, cohort5 |
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Time frame: up to Day 180
6 secondary outcomes
Pharmacokinetics (PK) of VSA012: Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 48 hours post-dose
PK of VSA012: Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to 48 hours post-dose
PK of VSA012: Area Under the Plasma Concentration Versus Time Curve
Time frame: Up to 48 hours post-dose
Change from Baseline in Serum Complement Factor B (CFB)
Time frame: Up to Day 180
Change from Baseline in Serum Complement Alternative Pathway (CAP)
Time frame: up to Day 180
The incidence of ADA
Time frame: up to 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 4 May 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 VSA012 in people with Healthy Volunteers, 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 4 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 4 May 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?
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs) (time frame: up to Day 180). 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 4 May 2026.