JPRN-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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 102
研究概览
简要总结
It was suggested that AMY109 has acceptable safety profile in single dose subcutaneous administration for healthy subjects, and multiple dose subcutaneous administration for patients with endometriosis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 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
研究者
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