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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Cohort1
干预措施: VSA012 (Drug)
Cohort1
干预措施: Placebo (Drug)
Cohort2
干预措施: Placebo (Drug)
Cohort2
干预措施: VSA012 (Drug)
cohort3
干预措施: VSA012 (Drug)
cohort3
干预措施: Placebo (Drug)
Cohort4
干预措施: VSA012 (Drug)
Cohort4
干预措施: Placebo (Drug)
cohort5
干预措施: VSA012 (Drug)
cohort5
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
时间窗: up to Day 180
次要结局
- 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)