This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Injection
Semnur Research Site 1
Boise, Idaho, United States
Change in Plasma Cortisol Concentrations From Baseline
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in plasma cortisol levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Time frame: 12 Weeks
Change in Blood Glucose Levels From Baseline
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in blood glucose levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Time frame: 12 Weeks
Change in White Blood Cell (WBC) Levels From Baseline
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in WBC levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Time frame: 12 Weeks
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average leg pain scores over 24 hours are presented.
Time frame: 12 weeks
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average back pain scores over 24 hours are presented.
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Time frame: 12 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence of treatment-emergent AEs (TEAEs) related to study drug.
Time frame: 12 weeks