A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of Pf-06342674 (RN168) In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes from baseline in safety laboratory assessments
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Male subjects and female of non-childbearing potential subjects between the ages of 18 and
- •BMI between 18.5 to 32 kg/m
- •Total body weight ≥40 kg and ≤120 kg.
排除标准
- •Previous treatment with an antibody within 6 months prior to Day
- •Pregnant or nursing females; females of childbearing potential.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
研究组 & 干预措施
2.0
干预措施: PF-06342674 Dose J (Biological)
2.0
干预措施: PF-06342674 Dose F (Biological)
1. Placebo
Placebo
干预措施: Placebo (Drug)
2.0
干预措施: PF-06342674 Dose A (Biological)
2.0
干预措施: PF-06342674 Dose B (Biological)
2.0
干预措施: PF-06342674 Dose C (Biological)
2.0
干预措施: PF-06342674 Dose D (Biological)
2.0
干预措施: PF-06342674 Dose E (Biological)
2.0
干预措施: PF-06342674 Dose G (Biological)
2.0
干预措施: PF-06342674 Dose H (Biological)
2.0
干预措施: PF-06342674 Dose I (Biological)
结局指标
主要结局
Changes from baseline in safety laboratory assessments
时间窗: 60 days
Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters
时间窗: 60 days
Incidence of anti-drug-antibodies
时间窗: 60 days
Severity of treatment emergent AEs
时间窗: 60 days
Causal relationship of treatment emergent AEs
时间窗: 60 days
Incidence of dose limiting or intolerable treatment related AEs
时间窗: 60 days
Incidence of treatment emergent AEs
时间窗: 60 days
Incidence of abnormal laboratory findings
时间窗: 60 days
次要结局
- Area under the Concentration-Time Curve (AUC)(60 days)
- Maximum Observed Plasma Concentration (Cmax)(60 days)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(60 days)
- PK parameter estimates including T1/2.(60 days)
- Systemic Clearance (CL)(60 days)
- Apparent Oral Clearance (CL/F)(60 days)
- Apparent Volume of Distribution (Vz/F)(60 days)