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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Spinal Cord Injury

Treatments: Biological: MT-3921 Low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT04096950

MT-3921-G01

Details and patient eligibility

About

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

Full description

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

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

MT-3921

Experimental group

Description:

Intravenous, single dose

Treatment:

Biological: MT-3921 Low dose