A Phase 2a, Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of a Single Dose of cP12 in Otherwise Healthy Adults With Up To and Including 10% Total Body Surface Area Thermal Burns
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events from dosing through follow-up
研究概览
简要总结
This is a Phase 2a, open-label, single-dose study to evaluate the safety, tolerability, and PK profile of cP12 in 6 male and female subjects with thermal burns of up to and including 10% TBSA. Enrolled subjects must have at least 1% superficial (epidermal), superficial partial-thickness, or deep partial-thickness burns.
Eligible subjects will receive a single administration of 0.01 mg/kg cP12. Vital signs, ECGs, and blood samples and urine samples will be obtained at screening and at several time points during the study for safety evaluation. Burn and pain assessments will be completed at specified times.
Subjects will remain at the clinical site for at least 6 hours post infusion for the purpose of safety monitoring and evaluation of other study assessments. Subsequent evaluations will be performed at the clinical site 3 (±1) days and 7 (±2) days after dosing.
Subjects will return to the clinical site 14 (±2) days after dosing for an End-of-Study visit.
详细描述
This is a Phase 2a, open-label, single-dose study to evaluate the safety, tolerability, and PK profile of cP12 in 6 male and female subjects with thermal burns of up to and including 10% TBSA. Enrolled subjects must have at least 1% superficial (epidermal), superficial partial-thickness, or deep partial-thickness burns. With the exception of the burns, subjects should be healthy and will be assessed to rule out smoke inhalation and other injuries. Vital signs prior to dosing must be stable and an electrocardiogram (ECG) must not show clinically significant abnormalities.
The target burn used in this study will be selected based on a burn classification description conducted prior to dosing with cP12. The selected burn must be superficial (epidermal), superficial partial-thickness, or deep partial-thickness and must not be a circumferential burn.
In the absence of burn-specific, validated assessment tools, NeoMatrix has developed scales to characterize the burn and surrounding tissues for this trial. Burn assessments will include erythema, capillary refill, blisters, and edema/swelling. In this trial, the target burn and all other burns of each subject will be assessed.
Eligible subjects will receive a single administration of 0.01 mg/kg cP12. Study drug will be administered over approximately 30 minutes by intravenous (IV) infusion with the subject in a supine position, and the infusion is to be initiated and completed within 2 to 24 hours after the burn has occurred. The subject is to remain in the supine position for 60 minutes from the start of study drug infusion (ie, during the 30-minute infusion and for 30 minutes after study drug infusion).
Vital signs, ECGs, and blood samples and urine samples will be obtained at screening and at several time points during the study for safety evaluation. Burn and pain assessments will be completed at specified times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •BMI between 18 kg/m2 (inclusive) and body weight >/=50kg
- •TBSA thermal burns up to and including 10%. The selected burn must be superficial (epidermal), superficial partial-thickness, or deep partial-thickness
- •Able to be infused with cP12 within 2 to 24 hours post burn
- •Able to follow birth control requirements
排除标准
- •Burns to the head, face and genitalia
- •Smoke inhalation
- •Active burn infection needing systemic antimicrobial treatment
- •Full-thickness burn in the target burn
- •Circumferential target burn
- •Clinically significant laboratory abnormality or other clinical findings indicative of an exclusionary disease or medical history
研究组 & 干预措施
Open-label
Six adult male or female subjects will receive a single administration of 0.01mg/kg of cP12.
干预措施: cP12 (Drug)
结局指标
主要结局
Incidence and severity of adverse events from dosing through follow-up
时间窗: Baseline, Day 1 (2,5,15,30,60,90,120,240,360 minutes postdose), Day 3, Day 7 and Day 14
Vital signs will be collected
Incidence and severity of adverse events from dosing through follow-up
时间窗: Day 1, Day 3 and Day 14
Clinical safety labs will be collected
Incidence and severity of adverse events from dosing through follow-up
时间窗: Day 1 (Baseline and 1hour, 6 hours postdose), Day 3 and Day 14
Electrocardiograms will be performed
次要结局
- Investigate pharmacokinetic profile(Predose, 2,5,15,30,60,120 and 240 minutes post dose)