A phase 1b study of S-151128 in participants with knee osteoarthritis

JRCT ID: jRCT2031230458

Registered date:19/11/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: patients with knee osteoarthritis
• Date of first enrollment: 19/12/2023
• Target sample size: 74
• Study type: Interventional
• Intervention(s): intravenous administration of S-151128 or placebo

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

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

Exclude criteria

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.

Related Information

• Primary Sponsor: Juan Carlos Gomez