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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MT-3921 Low dose
Sponsored by
Mitsubishi Tanabe Pharma America Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Medical Center
  • Northwestern University / Shirley Ryan Ability LAB (SRALAB)
  • Carle Foundation Hospital
  • University of Michigan
  • University of Mississippi Medical Center
  • Washington University School of Medicine
  • University of New Mexico Hospital
  • Carolinas Healthcare System / Atrium Health
  • Vidant Medical Center
  • The Ohio State University Wexner Medical Center
  • Thomas Jefferson University
  • VA Commonwealth Univ. School of Medicine
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MT-3921

Arm Description

Intravenous, single dose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 18, 2019
Last Updated
May 12, 2023
Sponsor
Mitsubishi Tanabe Pharma America Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04096950
Brief Title
Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury
Official Title
A Study to Investigate the Safety, Tolerability , Pharmacokinetics of Single Ascending Dose of MT-3921 in Subjects With Acute Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2020 (Actual)
Primary Completion Date
January 6, 2021 (Actual)
Study Completion Date
January 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma America Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury.
Detailed Description
This is a Phase 1, open-label, single ascending dose study of MT-3921 in subjects with spinal cord injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-3921
Arm Type
Experimental
Arm Description
Intravenous, single dose
Intervention Type
Biological
Intervention Name(s)
MT-3921 Low dose
Intervention Description
MT-3921 Low dose, intravenous, single dosing
Primary Outcome Measure Information:
Title
Percentage of subjects with adverse events within 6 months after single injection of MT-3921
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) profile (Cmax)
Description
PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
Time Frame
6 months post-dose
Title
PK profile (tmax)
Description
PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
Time Frame
6 months post-dose
Title
PK profile (t½)
Description
PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
Time Frame
6 months post-dose
Title
PK profile (AUC)
Description
PK samples will be collected at 0, 1, 4, 8 hours, 1, 2, 7 days, and 1, 2, 3, 6 months post-dose.
Time Frame
6 months post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Head of Clinical Development,
Organizational Affiliation
Mitsubishi Tanabe Pharma America Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Northwestern University / Shirley Ryan Ability LAB (SRALAB)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of New Mexico Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Carolinas Healthcare System / Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
VA Commonwealth Univ. School of Medicine
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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