NCT02217917已完成1 期
A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single And Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Rivipansel (pf 06460031) Following Subcutaneous Administration With Rhuph20 (pf 06744547) 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
- 27
- 试验地点
- 1
- 主要终点
- Assessment of clinical laboratory tests
研究概览
简要总结
This is a 2 part study designed to provide an initial assessment on the safety, tolerability, and PK of rivipansel, following single ascending (Part 1) and multiple ascending dosing (Part 2) given subcutaneously with rHuPH20, in healthy subjects. Part 1 of the study will be conducted using a cross-over design while Part 2 of the study will be conducted using a parallel design.
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.
- •Body Mass Index 17.5 - 30.5 kg/m2 and body weight >50 kg at Screening.
- •Normal skin without potentially obscuring features in the area intended for infusion.
- •Subjects willing to defer receiving prophylactic immunizations (eg, influenza or pneumococcal vaccines) during the study.
- •Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study
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).
- •History of a recent major surgery (within 3 months of screening).
- •Serious infection within 1 month of screening.
- •Subjects with chronic skin condition that may interfere in the assessment of emergent safety data.
- •A positive urine drug screen.
- •Known sensitivity to hyaluronidases.
- •History of hepatitis or positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibodies (HCV).
- •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.
研究组 & 干预措施
Cohort 3
Experimental
Multiple ascending dose
干预措施: Placebo (Drug)
Cohort 1
Experimental
Single ascending dose in 3 period cross-over design (with optional 4th period)
干预措施: Rivipansel (Drug)
Cohort 1
Experimental
Single ascending dose in 3 period cross-over design (with optional 4th period)
干预措施: Placebo (Drug)
Cohort 2
Experimental
Multiple ascending dose
干预措施: Rivipansel (Drug)
Cohort 2
Experimental
Multiple ascending dose
干预措施: Placebo (Drug)
Cohort 3
Experimental
Multiple ascending dose
干预措施: Rivipansel (Drug)
结局指标
主要结局
Assessment of clinical laboratory tests
时间窗: Baseline up to 7 days of dosing
Assessment of adverse events (AEs)
时间窗: Baseline up to 7 days of dosing
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG)
时间窗: Baseline up to 7 days of dosing
Assessment of vital signs (including blood pressure and pulse rate)
时间窗: Baseline up to 7 days of dosing
次要结局
- Apparent Clearance (CL/F) for rivipansel following single dose(Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following multiple dose(Days 1, 7)
- Peak to Trough Ratio (PTR) of plasma concentration for rivipanselmultiple dose administration(Day 7)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following single dose(Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration)
- Maximum Observed Plasma Concentration (Cmax) for rivipansel following multiple dose(Days 1, 7)
- Minimum Observed Plasma Concentration (Cmin) for rivipansel following multiple dose(Day 7)
- Maximum Observed Plasma Concentration (Cmax) for rivipansel following single dose(Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration)
- Apparent Volume of Distribution (Vz/F) for rivipansel following single dose(Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration)
- Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for rivipansel following multiple dose administration, where tau is 12 hours(Days 1, 7)
- Dose-Normalized Cmax for rivipansel following multiple dose administration(Days 1, 7)
- Dose-Normalized AUCtau for rivipansel following multiple dose administration(Days 1, 7)
- Plasma Decay Half-Life (t1/2) for rivipansel following multiple dose(Day 7)
- Dose-Normalized Cmax for rivipansel following single dose(Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration)
- Dose-Normalized AUCinf for rivipansel(Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration)
- Apparent Clearance (CL/F) for rivipansel following multiple dose(Day 7)
- Accumulation ratio for Area Under the Curve during the dosing interval (Rac) for rivipansel(Day 7)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for rivipansel following single dose(Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for rivipansel following single dose(Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration)
- Dose-Normalized AUClast for rivipansel(Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration)
- Plasma Decay Half-Life (t1/2) for rivipansel following single dose(Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration)
研究者
研究点 (1)
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