NCT01072591终止1 期
A Phase I, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess Safety,Tolerability, Pharmacokinetics and Efficacy of MEDI-578, an Anti-NGF Monoclonal Antibody, After Single Ascending Doses in Male and Non-fertile Female Patients With Painful Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Safety variables (adverse events, vital signs, ECG, safety lab)
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 MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will also be evaluated how MEDI-578 is absorbed and distributed through the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with painful osteoarthritis of the knee.
- •The pain from the knee must exceed pain experienced from any other condition.
- •Patients must be willing and able to discontinue all current analgesic treatment.
排除标准
- •Any other form of arthritis than osteoarthritis.
- •Presence of neuropathic pain, or fibromyalgia, or wide spread chronic pain not related to osteoarthritis.
- •Significant abnormalities on the clinical examination that may interfere with the study or present a safety risk to the patient, as judged by the investigator.
研究组 & 干预措施
1
Experimental
干预措施: MEDI-578 (Drug)
2
Placebo Comparator
干预措施: Placebo for MEDI-578 (Drug)
结局指标
主要结局
Safety variables (adverse events, vital signs, ECG, safety lab)
时间窗: Assessments performed at (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 2. Thereafter weekly assessments until week 4 when a fortnightly schedule is followed until week 8. A final assessment at week 12.
次要结局
- To characterize the pharmacokinetics of MEDI-578 in plasma.(Blood sampling performed at (predose, then ranging from every hour to every 24 hour) on Day 1 and 2. Thereafter weekly blood sampling until week 4, when a fortnightly schedule is followed until week 8. A final assessment at week 12.)
- To assess the immunogenicity of MEDI-578(Blood samples taken fortnightly from Day 1 until week 12.)
- To evaluate the analgesic efficacy of MEDI-578 during the night and day.(Patients will record their pain intensity every morning and evening during the 13 weeks study period.)
研究者
研究点 (1)
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