NCT01989143已完成1 期
A Phase 1, Randomzied, Double-blind, Third-party Open Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Intravenous And Multiple Subcutaneous And Intravenous Doses Of Pf-06480605 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
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Incidence and magnitude of abnormal laboratory findings.
研究概览
简要总结
This single and multiple ascending dose study is a first in human assessment of PF-06480605. The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 male and/or female subjects of non childbearing potential 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 and clinical laboratory tests).
- •Female subjects of non childbearing potential must meet at least one of the following criteria:
- •Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;
- •Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- •Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- •X-ray with no evidence of current, active TB or previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 3 months prior to Day 1 and read by a qualified radiologist.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Subjects with a history of or current positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV).
- •Subjects with a history of autoimmune disorders.
- •Subjects with a history of allergic or anaphylactic reaction to a therapeutic drug.
- •History of tuberculosis or active, latent or inadequately treated tuberculosis infection.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives or 180 days for biologics preceding the first dose of study medication.
- •Pregnant females; breastfeeding females; and females of childbearing potential.
研究组 & 干预措施
SAD Cohorts 1-8 Experimental Arm
Experimental
干预措施: PF-06480605 (Drug)
SAD Cohorts 1-8 Placebo Arm
Placebo Comparator
干预措施: Placebo (Drug)
MAD Cohorts 9-11 Experimental Arm
Experimental
干预措施: PF-06480605 (Drug)
MAD Cohorts 9-11 Placebo Arm
Placebo Comparator
干预措施: Placebo (Drug)
MAD Cohort 12 Experimental Arm
Experimental
干预措施: PF-06480605 (Drug)
MAD Cohort 12 Placebo Arm
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and magnitude of abnormal laboratory findings.
时间窗: 6 weeks
Abnormal and clinically relevant changes in vital signs, blood pressure (BP) and electrocardiogram (ECG) parameters.
时间窗: 6 weeks
Incidence of dose limiting or intolerability treatment related adverse events (AEs).
时间窗: 6 weeks
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) and withdrawals due to treatment emergent adverse events.
时间窗: 6 weeks
次要结局
- Multiple Ascending Dose Multiple Dose: Plasma Decay Half-Life (t1/2)(6 weeks)
- Multiple Ascending Dose Multiple Dose: Minimum Observed Plasma Trough Concentration (Cmin)(6 weeks)
- Single Ascending Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)(6 weeks)
- Single Ascending Dose: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)(6 weeks)
- Single Ascending Dose: Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast)(6 weeks)
- Multiple Ascending Dose First Dose: Maximum Observed Plasma Concentration (Cmax)(6 weeks)
- Multiple Ascending Dose First Dose: Dose normalized Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ [dn])(6 weeks)
- Single Ascending Dose: Dose normalized area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf[dn])(6 weeks)
- Single Ascending Dose: Mean residence time(MRT)(6 weeks)
- Single Ascending Dose: Dose normalized area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast[dn])(6 weeks)
- Single Ascending Dose: Plasma Decay Half-Life (t1/2)(6 weeks)
- Multiple Ascending Dose First Dose: Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ)(6 weeks)
- Multiple Ascending Dose Multiple Dose: Apparent Volume of Distribution (Vz/F)(6 weeks)
- Multiple Ascending Dose Multiple Dose: Systemic Clearance (CL)(6 weeks)
- Multiple Ascending Dose Multiple Dose: Observed accumulation ratio (Rac)(6 weeks)
- Multiple Ascending Dose Multiple Dose: Peak to trough fluctuation (PTF)(6 weeks)
- Single Ascending Dose: Area under the plasma concentration-time profile from time zero to 14 days (AUC14 days)(6 weeks)
- Single Ascending Dose: Dose normalized maximum plasma concentration (Cmax[dn])(6 weeks)
- Multiple Ascending Dose First Dose: Mean residence time (MRT)(6 weeks)
- Multiple Ascending Dose First Dose: Systemic Clearance (CL)(6 weeks)
- Multiple Ascending Dose Multiple Dose: Average concentration at steady state (Cav)(6 weeks)
- Single Ascending Dose: Maximum Observed Plasma Concentration (Cmax)(6 weeks)
- Single Ascending Dose: Systemic Clearance (CL)(6 weeks)
- Plasma Decay Half-Life (t1/2)(6 weeks)
- Apparent Volume of Distribution (Vz/F)(6 weeks)
- Multiple Ascending Dose First Dose: Volume of Distribution at Steady State (Vss)(6 weeks)
- Multiple Ascending Dose Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)(6 weeks)
- Single Ascending Dose: Volume of Distribution at Steady State (Vss)(6 weeks)
- Multiple Ascending Dose First Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)(6 weeks)
- Multiple Ascending Dose First Dose: Dose normalized maximum plasma concentration (Cmax[dn])(6 weeks)
- Multiple Ascending Dose Multiple Dose: Maximum Observed Plasma Concentration (Cmax)(6 weeks)
- Multiple Ascending Dose Multiple Dose: Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ)(6 weeks)
- Multiple Ascending Dose Multiple Dose: Apparent Oral Clearance (CL/F)(6 weeks)
- Multiple Ascending Dose First Dose: Apparent Oral Clearance (CL/F)(6 weeks)
- Multiple Ascending Dose Multiple Dose: Dose normalized maximum plasma concentration (Cmax[dn])(6 weeks)
- Multiple Ascending Dose Multiple Dose: Dose normalized Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ [dn])(6 weeks)
- Multiple Ascending Dose Multiple Dose: Volume of Distribution at Steady State (Vss)(6 weeks)
- Immunogenicity for both Single Ascending Dose and Multiple Ascending Dose: Development of anti-drug antibodies (ADA)(6 weeks)
- Multiple Ascending Dose Additional Parameter: estimate of bioavailability (F) for subcutaneous administration at the corresponding intravenous dose(6 weeks)
研究者
研究点 (1)
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