jRCT2080223785已完成1 期
A phase I, randomized, double-blind, placebo-controlled, inter-individual, ascending dose, multi-site study to assess the safety, tolerability, and pharmacokinetics of AMY109 after a single subcutaneous administration in healthy volunteers and after multiple subcutaneous administrations in patients with endometriosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Single And Multiple Sc Administrations, Randomized, Double-blind, Placebo-controlled, Inter-individual, Ascending Dose, Multi-site Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 64age old under（—）
- 性别
- All
入选标准
- •[Healthy male volunteers]
- •Aged => 20 and < 55 years
- •[Healthy female volunteers]
- •Non-child bearing potential or pre-menopausal aged => 20 and < 65 years
- •[Patients with endometriosis]
- •Aged => 20 and < 50 years
- •Patient has a moderate to severe pain for endometriosis for the screening period
排除标准
- •Any clinically significant abnormalities at the screening tests
- •History of hypersensitivity associated with antibody preparations and additive or excipients of AMY109
结局指标
主要结局
-
safety Observation / inspection
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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