Trials / Completed
CompletedNCT02193334
Phase I/II Study of KP-100IT in Acute Spinal Cord Injury
A Phase I/II Study to Evaluate the Safety and Efficacy of Intrathecal Injection of KP-100IT in Subjects With Acute Spinal Cord Injury
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Kringle Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KP-100IT | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-06-30
- Primary completion
- 2017-12-21
- Completion
- 2018-07-31
- First posted
- 2014-07-17
- Last updated
- 2019-06-05
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02193334. Inclusion in this directory is not an endorsement.