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一些更多的信息
http://clinicaltrials.gov/ct2/show/study/NCT01872065?term=arrowhead+research&rank=1
Some more information:
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 in Normal Adult Volunteers
Further study details as provided by Arrowhead Research Corporation:
Primary Outcome Measures:
To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520 [ Time Frame: One month ] [ Designated as safety issue: Yes ]
The incidence and frequency of adverse events (AEs), serious adverse events (SAEs), related AEs, related SAEs, and AEs leading to withdrawal, dose modification, or treatment discontinuation will be summarized by dose and treatment group.
Secondary Outcome Measures:
To evaluate the pharmacokinetics of ARC-520 at different dose concentrations [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Plasma concentrations following a single dose of ARC-520 at different dose levels will be used to calculate the following ARC-520 pharmacokinetic parameters: Cmax, tmax, AUC0-24, AUCinf, and t1/2. Descriptive statistics of pharmacokinetic parameters will include mean, standard deviation, and coefficient of variation.
Estimated Enrollment: 44
Study Start Date: July 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
研究类型:介入
研究设计:分配:随机
端点分类:安全性研究
介入模式:并行分配
屏蔽:双盲(主题,照顾者,研究者,成果评税)
主要目的:治疗
官方题名:A阶段随机,双盲,安慰剂对照,剂量递增研究,以评价其安全性,耐受性和药代动力学的ARC-520在正常成人志愿者
进一步研究细节箭头研究公司所提供的:
主要成果的措施:
要确定不良事件的发生率和频率作为衡量安全性和耐受ARC-520[时限:一个月] [指定安全问题:是]
将总结剂量和治疗组的不良事件(AE),严重不良事件(SAE),相关的不良事件,相关的严重不良反应,不良事件导致停药,调整剂量或停药的发生率和频率。
次要结局指标:
为了评估不同剂量浓度的ARC-520的药代动力学研究[时间框架:2天][指定安全问题:否]
将被用于在不同剂量水平的单剂量ARC-520后的血浆浓度,来计算以下ARC-520的药代动力学参数:tmax分别的Cmax,AUC 0-24,AUCinf,和t1/ 2。药代动力学参数,包括描述性统计均值,标准差,变异系数。
预计招生:44
研究开始日期:2013年7月
估计完成日期:10月2013(主要转归指标的最终数据收集日期)
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