A Phase 0, Single-Center Study to Evaluate the Safety and Tolerability of Injecting Sterile Saline Subcutaneously Into the Abdomen and Thigh of Healthy Volunteers Using Varying Volumes and Rates of Infusion
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Participant's Pain Intensity as Assessed by Verbal Pain Score (VPS)
研究概览
简要总结
The purpose of the study is to evaluate the influence of needle size, injected fluid volume, and rate of fluid on the degree of pain experienced by adult healthy volunteers after subcutaneous infusion of sterile saline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index greater than (>)18 and less than (<) 36
- •Able to understand the English language
- •Has a negative coronavirus-2019 (COVID-19) test result at the time of admission, prior to administration of study intervention
排除标准
- •Age < 18 years and > 60 years
- •BMI < 18 or > 36
- •Unable to understand the English language
- •Currently pregnant or lactating
- •History of skin sensitivity or allergy to steel needle or adhesive tape
- •History of abnormal blood coagulation or bleeding
- •History of abnormal immune function or frequent skin infections
- •Active cardiovascular, pulmonary, dermatologic, endocrine, rheumatologic, hematologic, ophthalmologic, psychiatric, metabolic, hepatic, renal, immune, gastrointestinal, neurological, or musculoskeletal disease
- •Has tattoo(s) or scarring at the site of injection or any other condition which may interfere with the injection site examination, in the opinion of the investigator
结局指标
主要结局
Participant's Pain Intensity as Assessed by Verbal Pain Score (VPS)
时间窗: Up to 10 minutes after completion of the saline solution
Participant's pain intensity during or after the saline infusion as assessed by VPS will be reported. VPS will be graded by participants as none, mild, moderate, and severe.
Participant's Pain Intensity as Assessed by Visual Analog Scale (VAS) Score
时间窗: Up to 10 minutes after completion of the saline infusion
Participant's pain intensity during or after the saline infusion as assessed by VAS score will be reported. VAS is a self-reported pain rating scale ranging 0=no pain to 100=worst possible pain.
次要结局
未报告次要终点