NCT01250587已完成1 期
A Dose-Escalating Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PDC31 in Patients With Primary Dysmenorrhea
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Occurrence of Dose-Limiting Toxicity
研究概览
简要总结
The purpose of this study is to determine a safe and effective dose range for intravenous administration (infusion) of PDC31 by determining the maximum tolerated dose of PDC31 in patients with primary dysmenorrhea.
详细描述
This is an open-label, multi-centre, dose-escalating first-in-human Phase I study of PDC31 in patients with primary dysmenorrhea aimed at determining the maximum tolerated dose (MTD) of PDC31 in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy females with a history of primary dysmenorrhea
- •Using effective birth control excluding intrauterine contraceptive device (IUCD)
- •Must be 18 years of age or older
- •Must give written informed consent to participate in this study
排除标准
- •Patients with an intrauterine contraceptive device or using oral contraceptives within 3 months of treatment in this study
- •Patients with confirmed pelvic inflammatory disease, endometriosis or adenomyosis
- •Patients who are pregnant or who test positive at baseline or are at risk of becoming pregnant while on study
- •Patients who are breastfeeding
- •Patients with hepatic or renal function tests greater than the upper limit of normal and deemed clinically significant by the Investigator at screening
- •Patients with a clinically significant medical or psychiatric disorder or a serious medical conditions within the past 6 months which in the opinion of the investigator, should prohibit participation in this study
- •Patients who have been exposure to any investigational drug within 4 weeks prior to screening
研究组 & 干预措施
PDC31
Experimental
干预措施: PDC31 (Drug)
结局指标
主要结局
Occurrence of Dose-Limiting Toxicity
时间窗: Observed following PDC31 administration to 30 day follow-up
次要结局
- Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility(Observed immediately following PDC31 administration)
研究者
研究点 (4)
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