A Phase 2 Double-blind, Randomized, Placebo-controlled Study to Determine the Safety, Tolerability and Potential Activity of AC105 Following a Regimen of 6 Doses Over 30 Hours in Patients With Acute Traumatic Spinal Cord Injury (SCI).
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 主要终点
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Saline
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.
干预措施: Placebo (Other)
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.
干预措施: AC105 (Drug)
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
时间窗: 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.
次要结局
- Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data(baseline, prior to and up to 5 hours following last infusion)