Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®)
试验速览
- 阶段
- 不适用
- 发起方
- Crossject
- 入组人数
- 86
- 主要终点
- Depth of the injection
研究概览
简要总结
The aim of this study is to evaluate the intramuscular nominal thigh injection performance and the low threshold strength thigh injection (by evaluating 2 low threshold : upper limit and lower limit). All participants will receive an intramuscular nominal thigh injection, and half of the participants will receive an intramuscular low threshold (upper limit) strength thigh injection, while the other half will receive an intramuscular low threshold (lower limit) strength thigh injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Male or female healthy volunteers aged between 18 and 60 years
- •Affiliated to or covered by the French social security system
- •BMI between ≥ 18 and < 30 kg/m²
- •Patients without chronic medical or surgical illness
- •Patients with normal clinical examination at the screening visit
- •Patients with normal blood pressure at the screening visit: systolic BP < 140 mmHg and diastolic BP < 90 mmHg, determined with the patient seated and resting for at least 5 minutes
- •Patient within normal range values for the following laboratory tests (appendix I) unless the investigator considers an abnormality to be clinically irrelevant (to be documented and agreed with the sponsor before inclusion) within 1 month prior to the start of the study.
- •Absence of cannabis, opiate, cocaine, amphetamine history
- •Written Informed consent
排除标准
- •History of drug abuse
- •History of hypersensitivity (disease or drug)
- •Treatment with platelet inhibiting drugs within one week before inclusion
- •Treatment with anticoagulant within four weeks before inclusion
- •Subject likely to take any medication during the study
- •Contra-indication to MRI: metallic intra-corporeal devices, claustrophobia
- •Prior participation to other interventional clinical research within 3 months
- •In custody due to administrative or legal decision or under tutelage or being admitted in a sanitary or social institution
- •pregnant or breastfeeding woman
研究组 & 干预措施
Group 1
Nominal strength thigh injection of 0.65ml of saline solution (0.9%) Low threshold (upper limit) strength thigh injection of 0.65ml of saline solution (0.9%)
干预措施: Intramuscular ZENEO® injection of nominal strength (Combination Product)
Group 1
Nominal strength thigh injection of 0.65ml of saline solution (0.9%) Low threshold (upper limit) strength thigh injection of 0.65ml of saline solution (0.9%)
干预措施: Intramuscular ZENEO® injection of low strength (upper limit) (Combination Product)
Group 2
Nominal strength thigh injection of 0.65ml of saline solution (0.9%) Low threshold (lower limit) strength thigh injection of 0.65ml of saline solution (0.9%)
干预措施: Intramuscular ZENEO® injection of nominal strength (Combination Product)
Group 2
Nominal strength thigh injection of 0.65ml of saline solution (0.9%) Low threshold (lower limit) strength thigh injection of 0.65ml of saline solution (0.9%)
干预措施: Intramuscular ZENEO® injection of low strength (lower limit) (Combination Product)
结局指标
主要结局
Depth of the injection
时间窗: 5 minutes after the injection
Depth of the injection (mm) by MRI
次要结局
未报告次要终点