JPRN-jRCT2031230458招募中1 期
A phase 1b, parallel-group, observer-blind, 2-arm, 2-dose study to investigate the safety and tolerability of intravenous S-151128 compared with placebo in male and female participants aged 40 to 75 with knee osteoarthritis
Juan Carlos Gomez0 个研究点目标入组 74 人开始时间: 2023年11月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 <= 75age old(—)
- 性别
- All
入选标准
- •Participant aged 40 to 75 years, inclusive, at the time of signing the informed consent.
- •Participants with knee osteoarthritis who meet the American College of Rheumatology classification criteria for idiopathic knee osteoarthritis and have the disease duration of >=3 months
排除标准
- •Current serious or medically unstable cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, or clinically significant abnormal laboratory test results or electrocardiogram findings, capable of constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.
- •Concurrent malignant tumor requiring treatment or a history of malignant tumor within the past 5 years.
- •Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- •Previously exposure to S-151128.
研究者
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