NCT04096950

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

April 19, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2021

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

September 18, 2019

Last Update Submit

May 12, 2023

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

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

    6 Months

Secondary Outcomes (4)

  • Pharmacokinetic (PK) profile (Cmax)

    6 months post-dose

  • PK profile (tmax)

    6 months post-dose

  • PK profile (t½)

    6 months post-dose

  • PK profile (AUC)

    6 months post-dose

Study Arms (1)

MT-3921

EXPERIMENTAL

Intravenous, single dose

Biological: MT-3921 Low dose

Interventions

MT-3921 Low doseBIOLOGICAL

MT-3921 Low dose, intravenous, single dosing

MT-3921

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

UC Davis Medical Center

Sacramento, California, 95816, United States

Location

Northwestern University / Shirley Ryan Ability LAB (SRALAB)

Chicago, Illinois, 60611, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of New Mexico Hospital

Albuquerque, New Mexico, 87131, United States

Location

Carolinas Healthcare System / Atrium Health

Charlotte, North Carolina, 28203, United States

Location

Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

VA Commonwealth Univ. School of Medicine

Richmond, Virginia, 23298, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Head of Clinical Development,

    Tanabe Pharma America, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 20, 2019

Study Start

April 19, 2020

Primary Completion

January 6, 2021

Study Completion

January 6, 2021

Last Updated

May 15, 2023

Record last verified: 2023-05

Locations

US(13)