Skip to main content
OpenTrials
Completed

NCT Number: NCT04096950

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

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UC Davis Medical Center, Sacramento, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-3921 Low dose

Biological

MT-3921 Low dose, intravenous, single dosing

Primary outcomes

  1. Percentage of subjects with adverse events within 6 months after single injection of MT-3921

    Time frame: 6 Months

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tanabe Pharma America, Inc.

Industry

Registry information

Official study title

A Study to Investigate the Safety, Tolerability , Pharmacokinetics of Single Ascending Dose of MT-3921 in Subjects With Acute Spinal Cord Injury

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 20, 2019
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.