Status:
COMPLETED
Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury
Lead Sponsor:
Tanabe Pharma America, Inc.
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury.
Detailed Description
This is a Phase 1, open-label, single ascending dose study of MT-3921 in subjects with spinal cord injury.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04096950
Start Date
April 19 2020
End Date
January 6 2021
Last Update
May 15 2023
Active Locations (13)
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1
UC Davis Medical Center
Sacramento, California, United States, 95816
2
Northwestern University / Shirley Ryan Ability LAB (SRALAB)
Chicago, Illinois, United States, 60611
3
Carle Foundation Hospital
Urbana, Illinois, United States, 61801
4
University of Michigan
Ann Arbor, Michigan, United States, 48109