NCT02458209已完成1 期
A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Comparability Study To Assess The Subcutaneous Pharmacokinetics And Pharmacodynamics Of Bococizumab In Healthy Adult Subjects For Comparisons Of Drug Substance Manufactured At Two Different Locations And Administration Via Prefilled Syringe Vs. Prefilled Pen
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 470
- 试验地点
- 10
- 主要终点
- Cmax
研究概览
简要总结
This is an open label, single dose, randomized, parallel group study in healthy adult subjects to assess the comparability of bococizumab administered in a prefilled syringe vs. prefilled pen and comparability between drug substance manufactured at Pfizer Andover vs. Boehringer Ingelheim Pharma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects between the ages of 18 and 65 years
- •Body Mass Index (BMI) 33.0 kg/m2 or lower; and a total body weight 60 to 90 kg (132 198 lbs) inclusive
- •Fasting LDL-C must be 80 to 200 mg/dL at two qualifying visits: initial screening (Days -28 to -14) and Day -
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Evidence or history of clinically significant disease or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
- •Any condition possibly affecting drug absorption.
- •Pregnant/breast feeding female subjects; male subjects with partners currently pregnant; male & female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception
- •History of allergic or anaphylactic reaction to any therapeutic or diagnostic mAb or molecules made of components of mAb
- •History of regular alcohol consumption : >7 drinks/wk (F) or 14 drinks/wk (M)
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Positive urine drug screen.
- •Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
- •Screening seated BP of 140/90 mm Hg or higher
- •Screening 12-lead ECG demonstrating QTc >450 or a QRS interval >120 msec
- •Subjects with prior exposure to bococizumab (also known as PF-04950615 or RN316) or other investigational PCSK9 inhibitors.
- •Treatment with marketed or investigational mAbs within 6 months or 5 half-lives of Day 1
- •Treatment with an investigational drug within 30 days or 5 half-lives of Day 1, and/or anticipated to take part in a clinical study during the duration of this study.
- •Use of prescription or nonprescription drugs within 7 days or 5 half-lives of Day 1;
- •Abnormal labs:
- •AST/SGOT or ALT/SGPT greater than or equal to 1.2 × ULN; total bilirubin greater than or equal to 1.5 × ULN; CK >1.5 × ULN or absolute value >600 U/L.
- •Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
- •Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
结局指标
主要结局
Cmax
时间窗: Day 1 - Day 85
maximal plasma concentration
AUCinf
时间窗: Day 1 - Day 85
area under the concentration time curve from time 0 extrapolated to infinite time (AUCinf)
Cmax for bococizumab using DS from Pfizer as comapred to DS from BIP
时间窗: Day 1 - Day 85
Cmax of bococizumab using drug substance (DS) manufactured by Pfizer vs. DS manufactured by BIP
AUCinf for bococizumab using DS from Pfizer as comapred to DS from BIP
时间窗: Day 1 - Day 85
Cmax of bococizumab using drug substance (DS) manufactured by Pfizer vs. DS manufactured by BIP
Cmax for bococizumab using PFS as comapred to PFP
时间窗: Day 1 - Day 85
Cmax of bococizumab administered via prefilled syringe vs. a prefilled pen
AUCinf for bococizumab using PFS as comapred to PFP
时间窗: Day 1 - Day 85
AUcinf of bococizumab administered via prefilled syringe vs. a prefilled pen
次要结局
- CL/F(Day 1 - Day 85)
- Tmax(Day 1 - Day 85)
- MaxELDL-C(Day 1 - Day 85)
- AUEClast(Day 1 - Day 85)
- Incidence of ADAs and neutralizing antibodies(Day 1 - 85)
- Titer for ADAs and neutralizing antibodies(Day 1 - 85)
- Incidence and severity of ISRs(Day 1 - 85)
- T1/2(Day 1 - Day 85)
- AUClast(Day 1 - Day 85)
- AUEClast using DS from Pfizer as compared to BIP, if applicable(Day 1 - Day 85)
- MaxELDL-C using PFS as compared to PFP, if applicable(Day 1 - Day 85)
- Tmax,LDL-C(Day 1 - Day 85)
- Vz/F(Day 1 - Day 85)
- MaxELDL-C using DS from Pfizer as compared to BIP, if applicable(Day 1 - Day 85)
- AUEClast using PFS as compared to PFP, if applicable(Day 1 - Day 85)
- Incidence, severity and causal relationship of treatment emergent AEs(Day 1 - 85)
- Incidence of abnormal and clinically relevant safety laboratory parameters(Day 1 - 85)
研究者
研究点 (10)
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