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

NCT07722962 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

  • Acute Spinal Cord Injury (SCI)

Interventions

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.

Sponsors & Collaborators

  • Kringle Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07722962 on ClinicalTrials.gov