drugset / Trial / NCT02193334

Phase I/II Study of KP-100IT in Acute Spinal Cord Injury

NCT02193334

Phase 1/2 Completed 45 enrolled Kringle Pharma, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is randomized, double-blind, placebo-controlled Phase I/II study designed to evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation for intrathecal injection, as a treatment for acute spinal cord injury. The study is conducted at two clinical sites in Japan.

Timeline

Start
2014-06-30
Primary completion
2017-12-21
Completion
2018-07-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator HEPATOPOIETIN-A Protein / enzyme biologic 0.6 mg Intrathecal

Indications