NCT02572245已完成1 期
A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Comparability Study To Assess The Pharmacokinetics Of Pf-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Area under the concentration curve (AUC 0-2wk)
研究概览
简要总结
This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult 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
- None
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 and/or 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, complete physical examination including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG), and clinical laboratory tests.
- •Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 pounds).
- •Chest X ray with no evidence of current, active TB or previous (inactive) TB, fungal or general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.
- •Female subjects of non childbearing potential must meet at least one of the following criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post menopausal state; b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; c. Have medically confirmed ovarian failure.
- •All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
排除标准
- •Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome).
- •History of relevant orthostatic hypotension, fainting spells or blackouts.
- •Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin
结局指标
主要结局
Area under the concentration curve (AUC 0-2wk)
时间窗: Day 1-Day 15
Maximum serum concentration (Cmax)
时间窗: Day 1 - Day 15
次要结局
- Time to reach the maximum serum concentration (Tmax)(Day 1 - Day 43)
- AUC extrapolated to infinity (AUC0 inf)(Day 1 - Day 43)
- Apparent clearance (CL/F)(Day 1 - Day 43)
- Terminal half life (t1/2)(Day 1 - Day 43)
- Volume of distribution (Vz/F),(Day 1 - Day 43)
- Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose(Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection)
- AUC from time 0 to the last time point with quantifiable concentration (AUCT)(Day 1 - Day 43)
- Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose(1, 3, 8, 12 and 24 hours post injection)
研究者
研究点 (2)
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