Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects
2020年6月16日 更新者:GlycoMimetics Incorporated
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
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.
研究概览
研究类型
介入性
注册 (实际的)
27
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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-
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Brussels、比利时、B-1070
- Pfizer Clinical Research Unit
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Cohort 1
Single ascending dose in 3 period cross-over design (with optional 4th period)
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Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion.
Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel).
The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
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实验性的:Cohort 2
Multiple ascending dose
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Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion.
Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel).
The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
|
实验性的:Cohort 3
Multiple ascending dose
|
Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion.
Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel).
The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Assessment of adverse events (AEs)
大体时间:Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG)
大体时间:Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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Assessment of vital signs (including blood pressure and pulse rate)
大体时间:Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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Assessment of clinical laboratory tests
大体时间:Baseline up to 7 days of dosing
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Baseline up to 7 days of dosing
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次要结果测量
结果测量 |
大体时间 |
---|---|
Maximum Observed Plasma Concentration (Cmax) for rivipansel following single dose
大体时间: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
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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
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following single dose
大体时间: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
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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
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for rivipansel following single dose
大体时间: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
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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
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for rivipansel following single dose
大体时间: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
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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
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Dose-Normalized Cmax for rivipansel following single dose
大体时间: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
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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
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Dose-Normalized AUClast for rivipansel
大体时间: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
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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
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Dose-Normalized AUCinf for rivipansel
大体时间: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
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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
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Plasma Decay Half-Life (t1/2) for rivipansel following single dose
大体时间: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
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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
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Apparent Clearance (CL/F) for rivipansel following single dose
大体时间: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
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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
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Apparent Volume of Distribution (Vz/F) for rivipansel following single dose
大体时间: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
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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
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Maximum Observed Plasma Concentration (Cmax) for rivipansel following multiple dose
大体时间:Days 1, 7
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Days 1, 7
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following multiple dose
大体时间:Days 1, 7
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Days 1, 7
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Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for rivipansel following multiple dose administration, where tau is 12 hours
大体时间:Days 1, 7
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Days 1, 7
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Dose-Normalized Cmax for rivipansel following multiple dose administration
大体时间:Days 1, 7
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Days 1, 7
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Dose-Normalized AUCtau for rivipansel following multiple dose administration
大体时间:Days 1, 7
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Days 1, 7
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Plasma Decay Half-Life (t1/2) for rivipansel following multiple dose
大体时间:Day 7
|
Day 7
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Minimum Observed Plasma Concentration (Cmin) for rivipansel following multiple dose
大体时间:Day 7
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Day 7
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Apparent Clearance (CL/F) for rivipansel following multiple dose
大体时间:Day 7
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Day 7
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Peak to Trough Ratio (PTR) of plasma concentration for rivipanselmultiple dose administration
大体时间:Day 7
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Day 7
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac) for rivipansel
大体时间:Day 7
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Day 7
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年10月1日
初级完成 (实际的)
2016年4月1日
研究完成 (实际的)
2016年4月1日
研究注册日期
首次提交
2014年8月13日
首先提交符合 QC 标准的
2014年8月13日
首次发布 (估计)
2014年8月15日
研究记录更新
最后更新发布 (实际的)
2020年6月18日
上次提交的符合 QC 标准的更新
2020年6月16日
最后验证
2020年6月1日
更多信息
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