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

Shionogi & Co., Ltd.0 个研究点目标入组 74 人开始时间: 2023年12月19日最近更新: 2024年4月13日

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•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

•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.

AEs, laboratory tests, vital signs, 12-lead ECG, and Imaging assessment of the knee

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