A Phase I Clinical Study of VSA012 in Healthy Volunteers

NCT06766929 · tracked via the Priya Life Science China tracker

Sponsor

Bisirna Therapeutics (Suzhou) Co., Ltd.

Phase

Phase 1

Started

2025-01-20

Last updated

2026-05-04

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

VSA012Placebo

VSA012: VSA012 injection

Placebo: Placebo

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs) — up to Day 180

Trial sites (1)

Facility	City	Region	Status
Peking University Third Hospital	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06766929 on ClinicalTrials.gov ↗ ← All trials in China