A Phase I Clinical Study of VSA012 in Healthy Volunteers

Bisirna Therapeutics (Suzhou) Co., Ltd.

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: VSA012; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06766929

VSA012-1001

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 5 patient groups

Cohort1

Experimental group

Treatment:

Drug: Placebo

Drug: VSA012

Cohort2

Experimental group

Treatment:

Drug: Placebo

Drug: VSA012

cohort3

Experimental group

Treatment:

Drug: Placebo

Drug: VSA012

Cohort4

Experimental group

Treatment:

Drug: Placebo

Drug: VSA012

cohort5

Experimental group

Treatment:

Drug: Placebo

Drug: VSA012