NCT00788294已完成1 期
Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Immunogenicity
研究概览
简要总结
The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy
- •BMI of 18-30 kg/m2
- •more than 50 kg bodyweight.
排除标准
- •exposure to biologic type drugs within the last 3 months
- •history of allergic or anaphylactic reaction to a biologic drug
- •use of tobacco- or nicotine containing products that is more than what is in 5 cigarettes per day
- •excessive alcohol use.
结局指标
主要结局
Immunogenicity
时间窗: 16 weeks
Subcutaneous bioavailability
时间窗: 16 weeks
Injection site reactions
时间窗: 16 weeks
次要结局
- Nerve growth factor levels(16 weeks)
研究者
研究点 (2)
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