Traumatic brain injury
Conditions
Brief summary
Primary safety endpoint: Safety of different doses of AST-004 as determined by the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs) occurring through Day 7., Primary pharmacodynamic endpoint: Physiologic effect of AST-004 as determined by the change in plasma GFAP from baseline/pre-dose through the dose-completion, 24 hours, Day 7, Day 14 and Day 30 timepoints. The effect at 24 hours will be of primary interest.
Detailed description
Clinical effect of AST-004 as determined by change in Rivermead symptom scores from baseline/pre-dose through Day 14., Cerebroprotective effect of AST-004 as determined by differences in neuronal integrity, membrane turnover, glial activation, and neuroinflammation, measured as changes in N-acetylaspartate, choline-containing compounds, and myo-inositol on conventional MR spectroscopy at 24 hours and Day 14, and by the difference between these timepoints
Interventions
DRUGAST-004
Sponsors
Astrocyte Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: Safety of different doses of AST-004 as determined by the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs) occurring through Day 7., Primary pharmacodynamic endpoint: Physiologic effect of AST-004 as determined by the change in plasma GFAP from baseline/pre-dose through the dose-completion, 24 hours, Day 7, Day 14 and Day 30 timepoints. The effect at 24 hours will be of primary interest. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical effect of AST-004 as determined by change in Rivermead symptom scores from baseline/pre-dose through Day 14., Cerebroprotective effect of AST-004 as determined by differences in neuronal integrity, membrane turnover, glial activation, and neuroinflammation, measured as changes in N-acetylaspartate, choline-containing compounds, and myo-inositol on conventional MR spectroscopy at 24 hours and Day 14, and by the difference between these timepoints | — |
Outcome results
None listed