A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
2017年1月30日 更新者：ReveraGen BioPharma, Inc.
A Phase 1 Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
The purpose of this study is to examine the safety, tolerability, and PK of various increasing single and multiple doses of VBP15 in healthy adult subjects.
研究概览
研究类型
介入性
注册 (实际的)
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
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Kansas
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Lenexa、Kansas、美国、66219
- PRA Health Sciences
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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 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
- For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.
Exclusion Criteria:
- For the MAD Study: Women of childbearing potential.
- Clinically significant abnormal laboratory parameters
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：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：VBP15- 0.1 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
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实验性的：VBP15- 0.3 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
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实验性的：VBP15- 1.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
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实验性的：VBP15- 3.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
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实验性的：VBP15- 8.0 mg/kg Fasting SAD
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
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实验性的：VBP15- 8.0 mg/kg Fed SAD
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high high calorie meal.
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实验性的：VBP15- 20.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.
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安慰剂比较：Placebo - SAD
Subjects were orally administered a placebo under fasted conditions.
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实验性的：VBP15- 1.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 1.0 mg/kg for 14 days under fasted conditions.
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实验性的：VBP15- 3.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 3.0 mg/kg for 14 days under fasted conditions.
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实验性的：VBP15- 9.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 9.0 mg/kg for 14 days under fasted conditions.
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实验性的：VBP15- 20.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 20.0 mg/kg for 14 days under fasted conditions.
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安慰剂比较：Placebo MAD
Subjects were orally administered placebo for 14 days under fasted conditions.
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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 |
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Number of Subjects With Adverse Effects After a Single Dose of VBP15
大体时间：Participants will be followed for the duration of hospital stay of 4 days
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Participants will be followed for the duration of hospital stay of 4 days
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Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose)
大体时间：Participants will be followed for the duration of hospital stay of 4 days
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Participants will be followed for the duration of hospital stay of 4 days
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Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15
大体时间：Participants will be followed for the duration of hospital stay of 4 days
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Participants will be followed for the duration of hospital stay of 4 days
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Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15
大体时间：Participants will be followed for the duration of hospital stay of 15 days
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Participants will be followed for the duration of hospital stay of 15 days
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Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose)
大体时间：Participants will be followed for the duration of hospital stay of 15 days
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Participants will be followed for the duration of hospital stay of 15 days
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Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15
大体时间：Participants will be followed for the duration of hospital stay of 15 days
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Participants will be followed for the duration of hospital stay of 15 days
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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1月1日
初级完成 (实际的)
2015年11月1日
研究完成 (实际的)
2016年5月1日
研究注册日期
首次提交
2015年3月2日
首先提交符合 QC 标准的
2015年4月8日
首次发布 (估计)
2015年4月14日
研究记录更新
最后更新发布 (实际的)
2017年3月10日
上次提交的符合 QC 标准的更新
2017年1月30日
最后验证
2016年11月1日
更多信息
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.