A phase 1b study of S-151128 in participants with knee osteoarthritis
- Conditions
- patients with knee osteoarthritis
- Registration Number
- JPRN-jRCT2031230458
- Lead Sponsor
- Juan Carlos Gomez
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 74
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AEs, laboratory tests, vital signs, 12-lead ECG, and Imaging assessment of the knee
- Secondary Outcome Measures
Name Time Method