A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PG110 (Anti-NGF Monoclonal Antibody) in Patients With Pain Attributed to Osteoarthritis of the Knee

Abbott2 个研究点分布在 1 个国家目标入组 56 人开始时间: 2009年8月最近更新: 2011年6月7日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Abbott
入组人数: 56
试验地点: 2
主要终点: The number and severity of adverse events

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (NGF).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Moderate to severe pain attributed to knee osteoarthritis

排除标准

•Significant comorbidity
•Significant pain states other than osteoarthritis
•Concomitant medications that might affect assessments

结局指标

主要结局

The number and severity of adverse events

时间窗: Three months

次要结局

Terminal elimination half-life(Three months)
Dose proportionality of the area under the serum concentration-time curve(Three months)
Pain in the index knee(Three months)
Western Ontario and McMaster Universities questionnaire(Three months)

研究者

发起方

Abbott

申办方类型

Industry

研究点 (2)

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