A Randomized, Double-blind, Placebo-controlled Parallel-group Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UC1010 Administered Subcutaneously, Single-dosing in Healthy Women (Part 1) and Multiple Dosing in PMDD Women (Part 2) - Phase I/II Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Premenstrual symptom severity
研究概览
简要总结
The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy women. The safety and tolerability of UC1010 is also evaluated in study part 1.
In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment groups are compared to one placebo group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Part 1 -Essentially healthy
- •Part 2 -Have PMDD according to DSM-IV verified in two menstrual cycles
排除标准
- •steroid hormonal treatment during the previous three months
- •treatment with psychopharmaceuticals or other treatment for PMS
- •history of or a significant medical condition ongoing
- •be pregnant or plan a pregnancy within the study period
研究组 & 干预措施
UC1010 low dose
干预措施: UC1010 (Drug)
UC1010 high dose
干预措施: UC1010 (Drug)
Vehicle
干预措施: Placebo (Drug)
结局指标
主要结局
Premenstrual symptom severity
时间窗: Daily Record of Severity of Problems (DRSP) measured during 4-5 months
次要结局
- Number of subjects with adverse events(During 1.5 month (starting from first dose))