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NCT Number: NCT06766929

A Phase I Clinical Study of VSA012 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VSA012

Drug

VSA012 injection

Placebo

Drug

Placebo

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

Sponsors and collaborators

Lead sponsor

Bisirna Therapeutics (Suzhou) Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 9, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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