NCT01091220已完成1 期
A Randomized, Single-center, Double-blind, Placebo-controlled Study to Explore the Effect of a Single Dose of Certolizumab Pegol 400 mg on Semen Quality in Healthy Male Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total sperm motility (%)
研究概览
简要总结
The primary objective of this study is to evaluate the effect of certolizumab pegol (CZP) on the quality of sperm obtained from healthy male volunteers.
详细描述
CZP is a PEGylated humanized Fab' fragment with specificity for human tumor necrosis factor alpha (TNFα). Evidence suggests that modulation of TNFα signaling may affect male spermatogenesis. Therefore, this study will compare semen quality parameters before and after a single 400 mg dose of CZP, or matched placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers with normal baseline semen quality parameters
排除标准
- •Previous participation in studies involving TNF inhibitors
- •Prior treatment with biologic response modifiers within 5 half-lives
- •History of trauma or surgery to the pelvis/genital area
- •Tests positive for tuberculosis, HIV, Hepatitis B or C
结局指标
主要结局
Total sperm motility (%)
时间窗: baseline to 99 days
Sperm morphology (%)
时间窗: Baseline to 99 days
次要结局
- Sperm vitality (%)(Baseline to 99 days)
- Semen volume (mL)(Baseline to 99 days)
- Sperm count (millions)(Baseline to 99 days)
- Non-progressive motility (%)(Baseline to 99 days)
- Progressive motility (%)(Baseline to 99 days)
- Sperm concentration (millions/mL)(Baseline to 99 days)
研究者
研究点 (1)
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