A Randomized, Double-blind, Vehicle-controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intradermally Administered AIV001 in Healing of Incisional Wounds
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds
详细描述
This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. A unique model was used to assess incisional scarring, safety and biomarker assessments. Women electing to have the abdominoplasty procedure were enrolled in the study and abdominal incisions were generated on the abdominal skin. Up to 10 incisions were made on abdominal skn and treated as assigned. And data collection was conducted up to day 49 when the subjects were exited from the study and the abdominoplasty procedure performed. Exploratory efficacy measures were collected and pharmacokinetic profiles determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Treating investigator will administer the study medication. Evaluating Investigator will perform the safety and efficacy evaluations.
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible for an abdominoplasty
- •Nonsmoker
- •Fitzpatrick I-IV
- •Weight >45Kg
- •BMI <= 35
排除标准
- •Existing scars in study area, active infection
- •Any medical history or present conditions that may increase the risk associated with study participation or investigational product administration and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
研究组 & 干预措施
0.033% versus Vehicle
One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle.
干预措施: AIV001 (Drug)
0.1% versus Vehicle
One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle.
干预措施: AIV001 (Drug)
0.3% versus Vehicle
One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle.
干预措施: AIV001 (Drug)
1% versus Vehicle
One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle.
干预措施: AIV001 (Drug)
结局指标
主要结局
Adverse events
时间窗: Day 1 through Day 49
Local and systemic adverse events
次要结局
- Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable)(Day 7 through 49)
- Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)(Day 7 through 49)
- 100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)(Day 7 through 49)