Relapsing-remitting Multiple Sclerosis (rrMS)
Conditions
Brief summary
To evaluate the safety, bio-distribution, and radiation dosimetry; and to optimize the Imaging Protocol of GEH120714 (18F) Injection. Study recruits healthy volunteers and participants with relapsing and remitting multiple sclerosis.
Interventions
DRUGArm 1 - GEH120714 (18F) Injection
Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).
Sponsors
Centre for Probe Development and Commercialization
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for all Participants: * The subject has a clinically normal or acceptable medical history and physical examination at screening. * The subject has an acceptable kidney function (eGFR \>60 mL/min/1.73m2) for administration of Gadolinium. * The subject has a trans-locator protein (TSPO) platelet assay conducted with documented results. Inclusion Criteria for all healthy volunteers: * The subject has no clinical history or signs of neurological impairment. * The subject has a normal MRI without central white white matter lesions. Inclusion Criteria specific for participants with relapsing and remitting results sclerosis (rrMS): * Subject with a previous diagnosis of rrMS, presenting with (a) clinically active disease at time of screening or, or preferentially, (b) clinically active disease at time of screening and having at least one gadolinium--enhanced lesion on MRI. * The subject at screening has a MRI scan of sufficient quality for Volume of Interest (VOI) definition and co-alignment with Positron Emission Tomography (PET).
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recording the occurrence of adverse events (AEs) to evaluate the safety of a single dose of GEH120714 (18F) Injection in healthy volunteers (HV) and participants with rrMS. | Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. | Record the occurrence of adverse events (AEs) to evaluate the safety of a single dose of GEH120714 (18F) Injection in healthy volunteers (HV) and participants with rrMS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood samples collected multiple periods post injection; and urine samples at periods post injection to count radioactivity to determine bio-distribution, internal radiation dosimetry and Effective Dose (E) in healthy volunteers (HV). | Time zero equals the date of contrast imaging and up to the evaluation of the images and the kinetic modelling of cerebral uptake of GEH120714 (18F) Injection, | Collect blood samples at multiple time periods up to 120 minutes post drug injection; and urine samples at multiple time periods up to 270 minutes post drug injection to count radioactivity to determine the bio-distribution, internal radiation dosimetry and Effective Dose (E) per protocol in healthy volunteers (HV). |
Countries
Canada
Outcome results
None listed