Evaluation of Safety, Pharmacokinetics and Immunomodulatory Effects of AB103, a CD28 Co-stimulatory Receptor Antagonist, in Patients Diagnosed With Necrotizing Soft Tissue Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Atox Bio Ltd
- 入组人数
- 43
- 试验地点
- 7
- 主要终点
- Number of Subjects With One or More Serious Adverse Events (SAEs)
研究概览
简要总结
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.
详细描述
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections.
Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections. The efficacy domains are:
- Clinical status domain
- Pharmacoeconomics domain
- Systemic and local inflammatory biomarker domain
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AB103 0.25 mg/kg
干预措施: AB103 (Drug)
AB103 0.5 mg/kg
干预措施: AB103 (Drug)
Placebo
Normal saline (0.9% sodium chloride)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With One or More Serious Adverse Events (SAEs)
时间窗: 28 days
A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria: * Results in death * Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred) * Requires or prolongs hospitalization * Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions) * Is a congenital anomaly or birth defect, or * Is an important and significant medical event.
Platelet (PLT) Count
时间窗: Screening and Day 7
Screening PLT results, Day 7 PLT results, and change in PLT from screening to Day 7
International Normalized Ratio (INR)
时间窗: Screening and Day 7
Screening INR results, Day 7 INR results, and change in INR from screening to Day 7. In general, the higher the INR value, the longer it takes for blood to form a clot.
QT Interval With Fridericia's Correction (QTcF)
时间窗: Pre-dose and up to 24 hours post-dose
Pre-dose QTcF, post-dose QTcF, change in QTcF from pre-dose to post-dose
Categorical Change in QTcF
时间窗: Pre-dose and up to 24 hours post-dose
Number and percentage of patients with a change in QTcF of \> 30 msec; number and percentage of patients with a change in QTcF of \> 60 msec
Number of Subjects With One or More Adverse Events (AEs) During the Treatment Period
时间窗: 7 days
An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.
Alanine Aminotransferase (ALT)
时间窗: Screening and Day 7
Screening ALT results, Day 7 ALT results, and change in ALT from screening to Day 7
Aspartate Aminotransferase (AST)
时间窗: Screening and Day 7
Screening AST results, Day 7 AST results, and change in AST from screening to Day 7
Area Under the Plasma Concentration Versus Time Curve (AUC)
时间窗: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Area under the plasma concentration versus time curve (AUC) from time zero to infinity following a single dose of study drug, obtained by noncompartmental methods. It is an integrated measure of study drug plasma exposure.
Maximum Plasma Concentration (Cmax)
时间窗: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Maximum plasma concentration (observed)
Alkaline Phosphatase (ALP)
时间窗: Screening and Day 7
Screening ALP results, Day 7 ALP results, and change in ALP from screening to Day 7
Total Bilirubin (Tbili)
时间窗: Screening and Day 7
Screening Tbili results, Day 7 Tbili results, and change in Tbili from screening to Day 7
Serum Creatinine (sCr)
时间窗: Screening and Day 7
Screening sCr results, Day 7 sCr results, and change in sCr from screening to Day 7
Albumin (Alb)
时间窗: Screening and Day 7
Screening Alb results, Day 7 Alb results, and change in Alb from screening to Day 7
Hemoglobin (Hgb)
时间窗: Screening and Day 7
Screening Hgb results, Day 7 Hgb results, and change in Hgb from screening to Day 7
Total White Blood Cell (WBC) Count
时间窗: Screening and Day 7
Screening WBC results, Day 7 WBC results, and change in WBC from screening to Day 7
Apparent Terminal Plasma Half-life (T1/2)
时间窗: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Apparent terminal plasma half-life (T1/2) is the amount of time for plasma concentrations to decline by 50%.
Clearance (CL)
时间窗: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Clearance (CL) is the volume of plasma completely cleared of drug per unit of time.
Apparent Volume of Distribution Under Steady State Conditions (Vss)
时间窗: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Apparent volume of distribution under steady state conditions (Vss) based on drug concentration in plasma
次要结局
- C-reactive Protein (CRP)(Screening and Day 7)
- Day 14 Sequential Organ Failure Assessment (SOFA) Score(14 days)
- Day 14 Sequential Organ Failure Assessment (SOFA) Score Less Than or Equal to 1(14 days)
- Hospital Length of Stay (LOS)(28 days)
- Intensive Care Unit-free Days (ICU-free Days)(28 days)
- Ventilator-free Days(28 days)