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Trial record 1 of 1 for:    MT-3921-G01
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Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT04096950
Recruitment Status : Completed
First Posted : September 20, 2019
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Development 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Biological: MT-3921 Low dose Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Safety, Tolerability , Pharmacokinetics of Single Ascending Dose of MT-3921 in Subjects With Acute Spinal Cord Injury
Actual Study Start Date : April 19, 2020
Actual Primary Completion Date : January 6, 2021
Actual Study Completion Date : January 6, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MT-3921
Intravenous, single dose
Biological: MT-3921 Low dose
MT-3921 Low dose, intravenous, single dosing




Primary Outcome Measures :
  1. Percentage of subjects with adverse events within 6 months after single injection of MT-3921 [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Pharmacokinetic (PK) profile (Cmax) [ Time Frame: 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.

  2. PK profile (tmax) [ Time Frame: 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.

  3. PK profile (t½) [ Time Frame: 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.

  4. PK profile (AUC) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096950


Locations
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United States, California
UC Davis Medical Center
Sacramento, California, United States, 95816
United States, Illinois
Northwestern University / Shirley Ryan Ability LAB (SRALAB)
Chicago, Illinois, United States, 60611
Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Mexico
University of New Mexico Hospital
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Carolinas Healthcare System / Atrium Health
Charlotte, North Carolina, United States, 28203
Vidant Medical Center
Greenville, North Carolina, United States, 27834
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
VA Commonwealth Univ. School of Medicine
Richmond, Virginia, United States, 23298
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Development America, Inc.
Investigators
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Study Director: Head of Clinical Development, Mitsubishi Tanabe Pharma Development America, Inc.
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Responsible Party: Mitsubishi Tanabe Pharma Development America, Inc.
ClinicalTrials.gov Identifier: NCT04096950    
Other Study ID Numbers: MT-3921-G01
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System