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

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

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Biological: MT-3921 Low dose

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • UC Davis Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University / Shirley Ryan Ability LAB (SRALAB)
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Healthcare System / Atrium Health
    • Greenville, North Carolina, United States, 27834
      • Vidant Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Virginia
    • Richmond, Virginia, United States, 23298
      • VA Commonwealth Univ. School of Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT-3921; Intravenous, single dose	Biological: MT-3921 Low dose; MT-3921 Low dose, intravenous, single dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with adverse events within 6 months after single injection of MT-3921	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) profile (Cmax)	PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.	6 months post-dose
PK profile (tmax)	PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.	6 months post-dose
PK profile (t½)	PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.	6 months post-dose
PK profile (AUC)	PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.	6 months post-dose

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma America Inc.
• Investigators: Study Director: Head of Clinical Development,, Mitsubishi Tanabe Pharma America Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2020
• Primary Completion (Actual): January 6, 2021
• Study Completion (Actual): January 6, 2021

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: MT-3921-G01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No