Healthy Volunteers
Conditions
Brief 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.
Interventions
DRUGVSA012
VSA012 injection
DRUGPlacebo
Placebo
Sponsors
Bisirna Therapeutics (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | up to Day 180 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) of VSA012: Maximum Observed Plasma Concentration (Cmax) | Up to 48 hours post-dose |
| PK of VSA012: Time to Maximum Observed Plasma Concentration (Tmax) | Up to 48 hours post-dose |
| PK of VSA012: Area Under the Plasma Concentration Versus Time Curve | Up to 48 hours post-dose |
| Change from Baseline in Serum Complement Factor B (CFB) | Up to Day 180 |
| Change from Baseline in Serum Complement Alternative Pathway (CAP) | up to Day 180 |
| The incidence of ADA | up to Day 180 |
Countries
China
Outcome results
None listed