The principal aim of this study was to establish the feasibility of rapid administration, safety, and tolerability of AC105 in patients with acute spinal cord injury.
To determine safety and tolerability of AC105 following a regimen of 6 intravenous doses over 30 hours in patients with acute non-penetrating traumatic spinal cord injury (SCI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Treatment-Emergent Adverse Events (TEAEs) are defined as AEs with date time of onset (or worsening) on or after the start date time of the first infusion and no more than 30 days after the end of the last infusion.
Time frame: up to 6 months
Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data
Measuring Maximum Measured Plasma Concentration (Cmax), Time to Maximum Measured Plasma Concentration (Tmax), Half-life calculated as In(2)/kel (T 1/2) and Area Under the Plasma Concentration versus time curve (AUC).
Time frame: baseline, prior to and up to 5 hours following last infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.