A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
2014年9月23日 更新者：Pfizer
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects
The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (预期的)
86
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
-
-
Connecticut
-
New Haven、Connecticut、美国、06511
- Pfizer Investigational Site
-
-
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 64年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive.
- Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive.
Exclusion Criteria:
- Presence or history of muscle disease (eg, polymyositis or rhabdomyolysis).
- Weight loss or gain of >5% within 30 days of Screening, as reported by subject.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, metabolic urologic, dermatologic, renal, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) and any other major disease.
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：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：2个
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
安慰剂比较：1个
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
安慰剂比较：4个
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
安慰剂比较：3个
|
Placebo for PF-06252616, IV infusion, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, IV infusion, repeat dose
10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
安慰剂比较：6个
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
安慰剂比较：7
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
|
安慰剂比较：5
Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
|
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo for PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Placebo for PF-06252616, Subcutaneous injection, single dose
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Placebo for PF-06252616, IV infusion, repeat dose
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Incidence of treatment related Adverse Events.
大体时间：Day 197
|
Day 197
|
|
Severity of treatment related Adverse Events.
大体时间：Day 197
|
Day 197
|
|
Incidence of abnormal lab findings.
大体时间：Day 197
|
Day 197
|
|
Magnitude of abnormal lab findings.
大体时间：Day 197
|
Day 197
|
|
Abnormal and clinically relevant changes in Blood Pressure.
大体时间：Day 197
|
Day 197
|
|
Abnormal and clinically relevant changes in Pulse Rate.
大体时间：Day 197
|
Day 197
|
|
Abnormal and clinically relevant changes in Respiratory Rate.
大体时间：Day 197
|
Day 197
|
|
Abnormal and clinically relevant changes in temperature.
大体时间：Day 197
|
Day 197
|
|
Abnormal and clinically relevant changes in ECG parameters.
大体时间：Day 197
|
Day 197
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA
大体时间：Through Day 113 post dosing
|
Through Day 113 post dosing
|
|
PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration)
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
PF-06252616 concentration in serum as measured by a validated PK assay for AUCinf (area under the curve serum concentration-time profile from time zero to infinity
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
PF-06252616 concentration in serum as measured by a validated PK assay for AUClast (area under the curve serum concentration from time zero to the time of the last quantifiable concentration)
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
PF-06252616 concentration in serum as measured by a validated PK assay for t1/2 (half-life time for the serum concentration to decrease by half).
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
PF-06252616 concentration in serum as measured by a validated PK assay for AUCτ (area under the curve serum concentration by dose interval)
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time)
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
PF-06252616 concentration in serum as measured by a validated PK assay for CL (rate of clearance from serum)
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
PF-06252616 concentration in serum as measured by a validated PK assay for CLss (rate of steady state clearance from serum in the repeat dose cohort)
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
PF-06252616 concentration in serum as measured by a validated PK assay for Vz /F(volume of distribution is the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.)
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
PF-06252616 concentration in serum as measured by a validated PK assay for Vss(volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
Steady state volume of distribution is the apparent volume of distribution at steady-state.)
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
|
PF-06252616 concentration in serum as measured by a validated PK assay for RAC (accumulation ratio for AUC)
大体时间：Through Day 197 post dosing
|
Through Day 197 post dosing
|
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。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2012年6月1日
初级完成 (实际的)
2014年8月1日
研究完成 (实际的)
2014年8月1日
研究注册日期
首次提交
2012年5月25日
首先提交符合 QC 标准的
2012年6月7日
首次发布 (估计)
2012年6月11日
研究记录更新
最后更新发布 (估计)
2014年9月25日
上次提交的符合 QC 标准的更新
2014年9月23日
最后验证
2014年9月1日
更多信息
与本研究相关的术语
其他研究编号
- B5161001
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.