NCT02766621已完成1 期
Phase 1, Randomized, Double-blind, Third-party Open Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous And Subcutaneous Doses Of Pf-06823859 In Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF 06823859 in healthy subjects.
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
- •Healthy female subjects of non childbearing potential and male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •History of active or latent tuberculosis (TB) regardless of treatment; positive Quantiferon - TB test.
- •Subjects with a history of autoimmune disorders.
- •Subjects with a history of or positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).
研究组 & 干预措施
Placebo injection SC/IV
Placebo Comparator
Placebo for injection SC/IV
干预措施: Placebo injection SC/IV (Drug)
PF-06823859
Active Comparator
Study Drug being used in the study
干预措施: PF-06823859 (Biological)
结局指标
主要结局
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs
时间窗: Dosing through approximately Day 189
Safety
次要结局
- Apparent Clearance (CL) of PF-06823859(Pre dose to approximately Day 189)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06823859 administered subcutaneously(Pre dose to approximately Day 189)
- Volume of Distribution at Steady State (Vss) of PF-06823859(Pre dose to approximately Day 189)
- C av of PF-06823859(Pre dose to approximately Day 189)
- Number of Participants With Anti-Drug Antibody (ADA) to PF-06823859(Pre dose to approximately Day 189)
- bioavailability of PF-06823859 subcutaneous doses compared to intravenous doses of PF-06823859(Pre dose to approximately Day 189)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06823859(Pre dose to approximately Day 189)
- Maximum Observed Plasma Concentration (Cmax) of PF-06823859(Pre dose to approximately Day 189)
- Plasma Decay Half-Life (t1/2)(Pre dose to approximately Day 189)
- AUCtau (dose normalized)(Pre dose to approximately Day 189)
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06823859(Pre dose to approximately Day 189)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06823859(Pre dose to approximately Day 189)
- Mean residence of time for PF-06823859(Pre dose to approximately Day 189)
- Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06823859(Pre dose to approximately Day 189)
研究者
研究点 (1)
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