A First-in-human, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single Doses of SAR443809 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs)
研究概览
简要总结
Primary objective
- The tolerability and safety of SAR443809 Secondary
- The PK parameters of SAR443809
- The PD activity of SAR443809
- The immunogenicity of SAR443809
详细描述
Screening: up to 56 days (Day -56 to Day -2). Treatment: 1 day (treatment on Day 1, study observation period from Day -1 to Day 3). Follow-up and end of study: 105 days after IMP administration (follow up visits from Day 5 to Day 78; End of study visit on Day 106). Total study duration for each participant: approximately 23 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having given written informed consent prior to undertaking any study-related procedure
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
SAR443809 and placebo dose 4 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 4
干预措施: Humanized anti-Factor Bb monoclonal antibody (Drug)
SAR443809 and placebo dose 1 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 1
干预措施: Humanized anti-Factor Bb monoclonal antibody (Drug)
SAR443809 and placebo dose 1 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 1
干预措施: Placebo (Drug)
SAR443809 and placebo dose 2 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 2
干预措施: Humanized anti-Factor Bb monoclonal antibody (Drug)
SAR443809 and placebo dose 2 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 2
干预措施: Placebo (Drug)
SAR443809 and placebo dose 3 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 3
干预措施: Humanized anti-Factor Bb monoclonal antibody (Drug)
SAR443809 and placebo dose 3 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 3
干预措施: Placebo (Drug)
SAR443809 and placebo dose 4 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 4
干预措施: Placebo (Drug)
SAR443809 and placebo dose 5 Arm
6 participants receiving SAR443809 and 2 receiving placebo, subcutaneous administration dose 5
干预措施: Humanized anti-Factor Bb monoclonal antibody (Drug)
SAR443809 and placebo dose 5 Arm
6 participants receiving SAR443809 and 2 receiving placebo, subcutaneous administration dose 5
干预措施: Placebo (Drug)
SAR443809 and placebo dose 6 Arm
Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 6
干预措施: Humanized anti-Factor Bb monoclonal antibody (Drug)
SAR443809 and placebo dose 6 Arm
Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 6
干预措施: Placebo (Drug)
SAR443809 and placebo dose 7 Arm
Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 7
干预措施: Humanized anti-Factor Bb monoclonal antibody (Drug)
SAR443809 and placebo dose 7 Arm
Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 7
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs)
时间窗: Baseline up to 23 weeks
Incidence of potentially Clinical laboratory abnormalities
时间窗: Baseline up to 23 weeks
次要结局
- PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax(Baseline up to 23 weeks)
- PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax(Baseline up to 23 weeks)
- PK parameters of SAR443809 for IV and SC administrations: Time corresponding to the last concentration above the limit of quantification (Clast tlast)(Baseline up to 23 weeks)
- PK parameters of SAR443809 for IV and SC administrations: total body clearance of a drug from the plasma calculated by dividing dose by AUC (CL)(Baseline up to 23 weeks)
- PK parameters of SAR443809 for SC administrations: absolute bioavailability (F)(Baseline up to 23 weeks)
- PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to tlast (AUClast)(Baseline up to 23 weeks)
- PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss)(Baseline up to 23 weeks)
- PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F)(Baseline up to 23 weeks)
- Complement alternative pathway activity (Wieslab AP and alternative pathway hemolytic activity [AH50])(Baseline up to 23 weeks)
- Complement classical pathway activity (Wieslab CP)(Baseline up to 23 weeks)
- Incidence of treatment -emergent Anti-SAR443809 antibodies(Baseline up to 23 weeks)
- PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-∞)(Baseline up to 23 weeks)
- PK parameters of SAR443809 for IV and SC administrations: Terminal half-life associated with the terminal slope (λz) (t1/2z)(Baseline up to 23 weeks)
- PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F)(Baseline up to 23 weeks)