Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tanabe Pharma America, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Additional screening criteria check may apply for qualification:
Provide written informed consent prior to beginning any study procedures
Cervical spinal cord injury that meet all of the following criteria:
* Classified as AIS A, AIS B or AIS C
* ISNCSCI neurological level of injury between C4 and C7 (for C4, the subject must have at least 1 point of motor activity between C5 to C7)
* UEMS ≤28 at Screening
Body mass index (BMI) \<40
You may not be if
Additional screening criteria check may apply for qualification:
Any concomitant injury that interferes with the procedures and examinations required by study protocol, including performance, interpretation or validity of neurological examinations
Poly-traumatic Injury as defined by Injury Severity Score (ISS) values \> 25
Penetrating spinal cord injuries
Complete transection of the spinal cord
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
History of anaphylaxis or clinically significant allergic reactions to any medication
History or presence of malignancy within the last 3 years prior to screening
Subjects with current SARS-CoV-2 infection (COVID-19)
Subjects with hereditary fructose intolerance
Psychoactive substance use disorder
Participation in any clinical trial of a new chemical entity within 12 weeks prior to Screening
