Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury

An Additional Phase 3, Multicenter Study of Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Spinal Cord Injury (SCI)
• Intervention / Treatment: Drug: KP-100IT

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Daichika Hayata; Phone Number: '+81-6-7653-6728; Email: hayata@kringle-pharma.com
• Study Contact Backup: Name: Yurika Abe; Phone Number: +81-6-7653-6728; Email: y.abe@kringle-pharma.com

Study Locations

• Japan
  • Fukuoka
    • Iizuka, Fukuoka, Japan, 820-8508
      • Japan Organization for Occupational Health and Safety Comprehensive Spinal Cord Injuries Center
      • Contact: Phone Number: +81-948-24-7500
  • Hokkaido
    • Bibai, Hokkaido, Japan, 072-0015
      • Japan Organization for Occupational Health and Safety Hokkaido Spinal Cord Injury Center
  • Tokyo
    • Musashimurayama, Tokyo, Japan, 208-0011
      • National Hospital Organization Murayama Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients whose AIS grade is A at 72 hours (± 6 hours) after injury
• age: 18 years to 89 years
• MRI imaging and other tests confirm the continuity of the spinal cord

Exclusion Criteria:

• The injury site is C1-C2 or C2-C3
• The patient with a spinal crd compression rate of 70% or higher.
• The patient in whom a spinal cord rupture is strongle suspected.
• The patient cannot start rehabilitation necessary for recovery of function at an early stage.
• External trauma or concurrent organ injury.
• High dose steroid therapy administered for the treatment of spinal cord injury
• History or concurrent presence of malignant tumor.
• It is inappropriate for the subject to be included in the study, in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KP-100IT	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration, 24 weeks	24 weeks after investigational product administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Time course of ASIA motor score (total/ upper extremity / lower upper extremity)	From baseline through 24 weeks
Time course of ASIA sensory score	From baseline through 24 weeks
Time course of AIS classification	From baseline through 24 weeks
Time course of modified Frankel classification	From baseline through 24 weeks
Time course of neurological level of injury	From baseline through 24 weeks
Percentage of subjects improving by at least 5 and 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration	12 weeks and 24 weeks after investigational product administration
Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100 after intrathecal administration	From dosing through 24weeks
Evaluation of adverse events	From the first drug administration through the end of the observation period (24 weeks)

Collaborators and Investigators

• Sponsor: Kringle Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Hepatocyte growth factor; KP-100IT; Intrathecal administration
• Additional Relevant MeSH Terms: Deafness, Autosomal Recessive 39
• Other Study ID Numbers: KP-100-ND005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No