A Phase I, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Ascending Doses Of PF-05335810 In Hypercholesterolemic Subjects, With One, Open-Label, Multiple Fixed Dosage Cohort
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 133
- 试验地点
- 7
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On stable daily doses of a statin for 45 days prior to receiving study treatment.
- •Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization.
排除标准
- •History of a cardiovascular or cerebrovascular event or procedure within one year of randomization.
- •Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).
研究组 & 干预措施
Cohort 6
干预措施: PF-05335810 Dose D (Biological)
Cohort 6
干预措施: Placebo (Biological)
Cohort 1
干预措施: PF-05335810 Dose A (Biological)
Cohort 2
干预措施: PF-05335810 Dose B (Biological)
Cohort 2
干预措施: Placebo (Biological)
Cohort 5
干预措施: PF-05335810 Dose E (Biological)
Cohort 2
干预措施: PF-04950615 Dose A (Biological)
Cohort 3
干预措施: PF-05335810 Dose C (Biological)
Cohort 3
干预措施: Placebo (Biological)
Cohort 4
干预措施: PF-05335810 Dose D (Biological)
Cohort 4
干预措施: Placebo (Biological)
Cohort 3
干预措施: PF-04950615 (Biological)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to Day 85/169 or Early Termination (ET)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Change From Baseline in Heart Rate
时间窗: Baseline, Day 1 to 85/169 or ET
Diastolic Blood Pressure
时间窗: Baseline, Day 1 to 85/169 or ET
Change From Baseline in Electrocardiogram (ECG) Parameters
时间窗: Baseline, Day 1 to 85/169 or ET
Number of Participants With Laboratory Test Values of Potential Clinical Importance
时间窗: Baseline, Day 1 to 85/169 or ET
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Number of Participants With Laboratory Test Values of Potential Clinical Importance
时间窗: Baseline up to Day 85/169 or Early Termination (ET)
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
次要结局
- Apparent Volume of Distribution (Vz/F)(Day1 pre-dose to Day 85/169 or ET)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)](Day1 pre-dose to Day 85/169 or ET)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](Day1 pre-dose to Day 85/169 or ET)
- Maximum Observed Plasma Concentration (Cmax)(Day1 pre-dose to Day 85/169 or ET)
- Apparent Oral Clearance (CL/F)(Day1 pre-dose to Day 85/169 or ET)
- Absolute Bioavailability (%F)(Day1 pre-dose to Day 85/169 or ET)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Day1 pre-dose to Day 85/169 or ET)
- Plasma Decay Half-Life (t1/2)(Day1 pre-dose to Day 85/169 or ET)