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

NCT02193334 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-06-05

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries

Interventions

DRUG

KP-100IT

DRUG

Placebo

Sponsors & Collaborators

  • Kringle Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Etsuro HASHIMURA · Kringle Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

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Entities

Drugs

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 NCT02193334 on ClinicalTrials.gov