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Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
Sponsor: Kringle Pharma, Inc.
Summary
This is a Phase 3, multicenter, open-label, single-arm additional study to evaluate the efficacy of intrathecal KP-100IT in patients with acute spinal cord injury. Eligible patients will receive KP-100 0.6 mg/body by intrathecal administration once per week for a total of 5 doses and will be followed for approximately 24 weeks after the first dose.
Official title: An Additional Phase 3, Multicenter Study of Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-07-31
Completion Date
2028-12-31
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
KP-100IT
The contents of each vial were dissolved in the distilled water for injection, and the study drug (0.6 mg as KP-100) was administered intrathecally once per week a total of 5 times.
Locations (3)
Japan Organization for Occupational Health and Safety Comprehensive Spinal Cord Injuries Center
Iizuka, Fukuoka, Japan
Japan Organization for Occupational Health and Safety Hokkaido Spinal Cord Injury Center
Bibai, Hokkaido, Japan
National Hospital Organization Murayama Medical Center
Musashimurayama, Tokyo, Japan