Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury

Drug
General health
Online since 16 April 2024, updated 233 days ago

About this trial

This is a clinical trial to assess the safety, tolerability and pharmacokinetics (i.e. what the body does to a drug) of an experimental drug (MT-3921) in persons with spinal cord injury. If included, the participant will receive a single low dose of the MT-3921 drug injected into a vein. If the drug seems to be well tolerated, the participant will receive a high dose of the MT-3921 drug. Blood samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months after receiving the drug. This drug is an antibody treatment that has been shown in animal studies (e.g. mice and monkeys) to act against molecules that prevent guidance of regenerating nerve fibres.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C4 - C8
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≥ 0 hours
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C4-C8
    Additionally, participants must
    have a neurological level of injury between C4 and C8.
    have one of the following ASIA impairment scale (AIS) classification:
    AIS A: complete; no feeling or movement below the injury

    What’s involved

    Type

    Drug

    Details

    The participant will receive a single low dose of the MT-3921 drug injected into a vein. If the drug seems to be well tolerated, the participant will receive a high dose of the MT-3921 drug. Blood samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months after receiving the drug.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Ended
    • Trial start date
    • 19 Apr 2020
    • Organisation
    • Mitsubishi Tanabe Pharma America Inc.
    • Trial recruitment status
    • Ended
    • Trial start date
    • 19 Apr 2020
    • Organisation
    • Mitsubishi Tanabe Pharma America Inc.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more