Clinical trial NCT04096950: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spinal Cord Injury
Lead sponsor: Mitsubishi Tanabe Pharma America Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of subjects with adverse events within 6 months after single injection of MT-3921
timeFrame: 6 Months
Secondary outcomes:
measure: Pharmacokinetic (PK) profile (Cmax)
timeFrame: 6 months post-dose
measure: PK profile (tmax)
timeFrame: 6 months post-dose
measure: PK profile (t½)
timeFrame: 6 months post-dose
measure: PK profile (AUC)
timeFrame: 6 months post-dose
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University / Shirley Ryan Ability LAB (SRALAB)
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
city: Charlotte
country: United States
facility: Carolinas Healthcare System / Atrium Health
state: North Carolina
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Richmond
country: United States
facility: VA Commonwealth Univ. School of Medicine
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Mitsubishi Tanabe Pharma America Inc.
name: Head of Clinical Development,
role: STUDY_DIRECTOR
References: