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

Phase 1

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT04096950
• Lead Sponsor: Mitsubishi Tanabe Pharma America Inc.

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.

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Study Start: 2020-04-19
• Primary Completion: 2021-01-06
• Study Completion: 2021-01-06
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with adverse events within 6 months after single injection of MT-3921	6 Months

Secondary Outcome Measures

Name	Time	Method
PK profile (t½)	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.
PK profile (AUC)	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.
Pharmacokinetic (PK) profile (Cmax)	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.
PK profile (tmax)	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.

Trial Locations

Locations (13)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

Northwestern University / Shirley Ryan Ability LAB (SRALAB); 🇺🇸 Chicago, Illinois, United States

Carle Foundation Hospital; 🇺🇸 Urbana, Illinois, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University of New Mexico Hospital; 🇺🇸 Albuquerque, New Mexico, United States

Carolinas Healthcare System / Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Vidant Medical Center; 🇺🇸 Greenville, North Carolina, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

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