Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury
NCT ID: NCT04096950
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
3 participants
INTERVENTIONAL
2020-04-19
2021-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MT-3921
Intravenous, single dose
MT-3921 Low dose
MT-3921 Low dose, intravenous, single dosing
Interventions
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MT-3921 Low dose
MT-3921 Low dose, intravenous, single dosing
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma America Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Head of Clinical Development,
Role: STUDY_DIRECTOR
Mitsubishi Tanabe Pharma America Inc.
Locations
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UC Davis Medical Center
Sacramento, California, United States
Northwestern University / Shirley Ryan Ability LAB (SRALAB)
Chicago, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Carolinas Healthcare System / Atrium Health
Charlotte, North Carolina, United States
Vidant Medical Center
Greenville, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
VA Commonwealth Univ. School of Medicine
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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MT-3921-G01
Identifier Type: -
Identifier Source: org_study_id
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