Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury.

Official Title

A Study to Investigate the Safety, Tolerability , Pharmacokinetics of Single Ascending Dose of MT-3921 in Subjects With Acute Spinal Cord Injury

Details

This is a Phase 1, open-label, single ascending dose study of MT-3921 in subjects with spinal cord injury.

Keywords

Spinal Cord Injury Spinal Cord Injuries Wounds and Injuries MT-3921 Low dose MT-3921 High dose

Eligibility

You can join if…

Open to people ages 18-65

Additional screening criteria check may apply for qualification:

  • Provide written informed consent prior to beginning any study procedures
  • Cervical spinal cord injury, ASIA impairment scale grade A, B, and C with the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological level of injury between C4 and C8
  • Male or female subjects aged between 18 and 65 years
  • Body mass index (BMI) <35
  • Has had stabilization surgery (if needed) following their SCI and prior to receiving MT-3921

You CAN'T join if...

Additional screening criteria check may apply for qualification:

  • Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations
  • Poly-traumatic Injury as defined by Injury Severity Score (ISS) values > 25
  • Penetrating spinal cord injuries
  • Traumatic transection of the spinal cord or spinal cord contusion size > 3 cm determined by MRI
  • Any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the iInvestigator, may increase the risks associated with study participation
  • Subjects with HIV, HBV or HCV positive
  • Psychoactive substance use disorder
  • History or presence of malignancy within the last 5 years prior to screening
  • Pregnant or nursing women
  • Subjects with hereditary fructose intolerance
  • History of anaphylaxis or significant allergy

Locations

  • UC Davis Medical Center not yet accepting patients
    Sacramento California 95816 United States
  • University of Southern California withdrawn
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mitsubishi Tanabe Pharma Development America, Inc.
Links
Sign up for this study
ID
NCT04096950
Phase
Phase 1
Study Type
Interventional
Last Updated