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Active, not recruitingNCT06766929Updated May 4, 2026

A Phase I Clinical Study of VSA012 in Healthy Volunteers

A Phase 1 interventional study of VSA012 and Placebo in Healthy Volunteers, sponsored by Bisirna Therapeutics (Suzhou) Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Bisirna Therapeutics (Suzhou) Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Healthy Volunteers
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In context

Lead sponsor

Bisirna Therapeutics (Suzhou) Co., Ltd. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Cohort1

    Drug: VSA012 · Drug: Placebo

  • Experimental
    Cohort2

    Drug: VSA012 · Drug: Placebo

  • Experimental
    cohort3

    Drug: VSA012 · Drug: Placebo

  • Experimental
    Cohort4

    Drug: VSA012 · Drug: Placebo

  • Experimental
    cohort5

    Drug: VSA012 · Drug: Placebo

Interventions

  • DrugVSA012

    VSA012 injection

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)

    Time frame: up to Day 180

Secondary outcomes

  1. Pharmacokinetics (PK) of VSA012: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to 48 hours post-dose

  2. PK of VSA012: Time to Maximum Observed Plasma Concentration (Tmax)

    Time frame: Up to 48 hours post-dose

  3. PK of VSA012: Area Under the Plasma Concentration Versus Time Curve

    Time frame: Up to 48 hours post-dose

  4. Change from Baseline in Serum Complement Factor B (CFB)

    Time frame: Up to Day 180

  5. Change from Baseline in Serum Complement Alternative Pathway (CAP)

    Time frame: up to Day 180

  6. The incidence of ADA

    Time frame: up to Day 180

07

Study locations

1 site
  • Peking University Third Hospital
    Beijing, Beijing Municipality, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06766929
Lead sponsor
Bisirna Therapeutics (Suzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Jan 9, 2025
Start date
Jan 20, 2025
Primary completion
Aug 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
May 4, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Bisirna Therapeutics (Suzhou) Co., Ltd.

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