AC105 in Patients With Acute Traumatic Spinal Cord Injury

Recruitment & Eligibility

Inclusion Criteria

Male or female between 18 and 65 years of age, inclusive
Acute traumatic SCI, at a neurological level between C4 and T11
No evidence of penetrating or transection injury (e.g. caused by projectile or stab wound)
Neurological ASIA Impairment Scale A, B or C
Patient is able to provide written or verbal witnessed consent. If unable to provide either, consent may be provided by legally authorized representative (LAR)
Patient is able to initiate treatment within time window of injury

Exclusion Criteria

Known allergy or hypersensitivity to polyethylene glycol
Mental impairment or other conditions that would preclude a reliable ASIA exam or adequate consent
Positive urine pregnancy test result
Serum creatinine level ≥ 2 mg/dL
History or active renal failure or dialysis
Mean arterial blood pressure < 60 mmHg despite vasopressor treatment
On a current regimen of digoxin
Chronic use of magnesium salts prior to the SCI (within 1week of presentation) and/or the use of magnesium salts in the acute care setting prior to the administration of investigational product
Any other medical condition that, in the judgment of the investigator, would preclude provision of informed consent, make participation in the study unsafe, or unreasonably complicate follow-up or the interpretation of study outcome data or may otherwise interfere with achieving the study objectives
In the judgment of the Investigator, cannot adequately provide informed consent, is likely to be non-compliant, or may be unable to cooperate with study requirements

Study & Design

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.
AC105	AC105	Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	up to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data	baseline, prior to and up to 5 hours following last infusion	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).

Recruitment & Eligibility