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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04096950
• Other study ID #: MT-3921-G01
• Status: Completed
• Phase: Phase 1
• Start date: April 19, 2020
• Est. completion date: January 6, 2021

Study information

• Verified date: May 2023
• Source: Mitsubishi Tanabe Pharma America Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Biological:
• MT-3921 Low dose
MT-3921 Low dose, intravenous, single dosing

Locations

Country	Name	City	State
United States	University of New Mexico Hospital	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Carolinas Healthcare System / Atrium Health	Charlotte	North Carolina
United States	Northwestern University / Shirley Ryan Ability LAB (SRALAB)	Chicago	Illinois
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Vidant Medical Center	Greenville	North Carolina
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	VA Commonwealth Univ. School of Medicine	Richmond	Virginia
United States	UC Davis Medical Center	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Carle Foundation Hospital	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma America Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with adverse events within 6 months after single injection of MT-3921		6 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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