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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The number and severity of adverse events
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
研究组 & 干预措施
Placebo
single, slow intravenous infusion that matches PG110 in appearance
干预措施: Placebo (Biological)
Eight Dose of PG110
single, slow intravenous infusion
干预措施: PG110 (Biological)
Seventh Dose of PG110
single, slow intravenous infusion
干预措施: PG110 (Biological)
Top dose of PG110
single, slow intravenous infusion
干预措施: PG110 (Biological)
Fifth dose of PG110
single, slow intravenous infusion
干预措施: PG110 (Biological)
Fourth dose of PG110
single, slow intravenous infusion
干预措施: PG110 (Biological)
Third dose of PG110
single, slow intravenous infusion
干预措施: PG110 (Biological)
Second dose of PG110
single, slow intravenous infusion
干预措施: PG110 (Biological)
Lowest dose of PG110
single, slow intravenous infusion
干预措施: PG110 (Biological)
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)