A Phase 1, Randomized, Double- Blind (Sponsor-Open), Placebo-Controlled Study To Examine The Density Of Intraepidermal Nerve Fibers After A Single Subcutaneous Administration Of Tanezumab In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- To assess the change in intraepidermal nerve fiber (IENF) density in skin biopsies from proximal thigh and distal leg between baseline and postdose time points after a single SC injection of tanezumab 20 mg SC or placebo in healthy volunteers.
研究概览
简要总结
Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.
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
- Double (Participant, Care Provider)
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
- •Healthy subjects only
- •Female subjects can not be pregnant or be nursing.
- •Females and males need to use two types of birth control methods during the length of the study and one of the two methods needs to be a barrier method.
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Subject can not have any chronic or acute medical condition or have had any chronic illness in the past
- •Can not have any problematic skin condition.
- •Females can not have more than 7 alcoholic drinks per week and males can not have more than 14 alcoholic drinks per week
研究组 & 干预措施
placebo
formulation without active drug
干预措施: placebo (Other)
tanezumab
干预措施: tanezumab (Biological)
结局指标
主要结局
To assess the change in intraepidermal nerve fiber (IENF) density in skin biopsies from proximal thigh and distal leg between baseline and postdose time points after a single SC injection of tanezumab 20 mg SC or placebo in healthy volunteers.
时间窗: 16 weeks
To compare the treatment effect between tanezumab 20 mg SC and placebo on the change in IENF density between baseline and postdose time points in skin biopsies from the proximal thigh and distal leg in healthy volunteers.
时间窗: 16 weeks
To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers.
时间窗: 16 weeks
次要结局
- To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers(16 weeks)