Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury
- Conditions
- Spinal Cord Injury
- Interventions
- Biological: MT-3921 Low dose
- Registration Number
- NCT04096950
- Lead Sponsor
- Mitsubishi Tanabe Pharma America Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MT-3921 MT-3921 Low dose Intravenous, single dose
- Primary Outcome Measures
Name Time Method Percentage of subjects with adverse events within 6 months after single injection of MT-3921 6 Months
- Secondary Outcome Measures
Name Time Method PK profile (t½) 6 months post-dose PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
PK profile (AUC) 6 months post-dose PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
Pharmacokinetic (PK) profile (Cmax) 6 months post-dose PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
PK profile (tmax) 6 months post-dose PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
Trial Locations
- Locations (13)
Vidant Medical Center
🇺🇸Greenville, North Carolina, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Northwestern University / Shirley Ryan Ability LAB (SRALAB)
🇺🇸Chicago, Illinois, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of New Mexico Hospital
🇺🇸Albuquerque, New Mexico, United States
Carolinas Healthcare System / Atrium Health
🇺🇸Charlotte, North Carolina, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
VA Commonwealth Univ. School of Medicine
🇺🇸Richmond, Virginia, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States