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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230458

Enrollment

Registered

2023-11-19

Start date

2023-12-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with knee osteoarthritis

Interventions

intravenous administration of S-151128 or placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

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

Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026