Spinal Cord InjuryPhase 1NCT04096950
Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury
A Phase 1 study testing MT-3921 Low dose in people with Spinal Cord Injury, run by Tanabe Pharma America, Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- MT-3921 Low dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 13 sitesUnited States
- Study dates
- 19 Apr 2020to 6 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of New Mexico Hospital
Albuquerque, New Mexico, 87131
University of Michigan
Ann Arbor, Michigan, 48109
Carolinas Healthcare System / Atrium Health
Charlotte, North Carolina, 28203
Northwestern University / Shirley Ryan Ability LAB (SRALAB)
Chicago, Illinois, 60611
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Vidant Medical Center
Greenville, North Carolina, 27834
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
VA Commonwealth Univ. School of Medicine
Richmond, Virginia, 23298
UC Davis Medical Center
Sacramento, California, 95816
Washington University School of Medicine
St Louis, Missouri, 63110
Carle Foundation Hospital
Urbana, Illinois, 61801
About this study
Official title: A Study to Investigate the Safety, Tolerability , Pharmacokinetics of Single Ascending Dose of MT-3921 in Subjects With Acute Spinal Cord Injury
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury.
Read the detailed description
This is a Phase 1, open-label, single ascending dose study of MT-3921 in subjects with spinal cord injury.
- Conditions
- Spinal Cord Injury
- Being tested
- MT-3921 Low dose
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-3921 Low doseBiological
MT-3921 Low dose, intravenous, single dosing
| Study group | Role | What they receive |
|---|---|---|
| MT-3921 | Experimental | Intravenous, single dose Receives: Biological: MT-3921 Low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with adverse events within 6 months after single injection of MT-3921
Measured: 6 Months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start19 Apr 2020
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Clinical Development,, Study director, Tanabe Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096950
- Sponsor's protocol ID
- MT-3921-G01
- Status last verified
- May 2023
- First submitted
- 18 Sep 2019
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Safety, Tolerability , Pharmacokinetics of Single Ascending Dose of MT-3921 in Subjects With Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04096950
- Acronym / sponsor ID
- MT-3921-G01
- Conditions
- Spinal Cord Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Tanabe Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2020 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MT-3921 | Experimental | Biological: MT-3921 Low doseIntravenous, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-3921 Low doseMT-3921 Low dose, intravenous, single dosing | Biological | MT-3921 |
Primary outcome
Percentage of subjects with adverse events within 6 months after single injection of MT-3921
Time frame: 6 Months
4 secondary outcomes
Pharmacokinetic (PK) profile (Cmax)
Time frame: 6 months post-dose
PK profile (tmax)
Time frame: 6 months post-dose
PK profile (t½)
Time frame: 6 months post-dose
PK profile (AUC)
Time frame: 6 months post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Head of Clinical Development, study director
Tanabe Pharma America, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-3921 Low dose in people with Spinal Cord Injury, run by Tanabe Pharma America, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with adverse events within 6 months after single injection of MT-3921 (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.