Performance Thresholds Evaluation by Wet Injection Quantification and Magnetic Resonance Imaging (MRI) of Subcutaneous and Intramuscular Injections (0,65ml) of Several Configurations of Needle-free Devices (ZENEO®)

Study Overview
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Brief Summary
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The aim of this study is to evaluate the performance of the ZENEO needle free device in subcutaneous functioning limits (low performance limit and high performance limit) and for intramuscular injections.

Conditions
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No Condition

Intervention / Treatment
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* Combination Product: Intramuscular ZENEO® injection
* Combination Product: Subcutaneous high ZENEO® injection
* Combination Product: Subcutaneous low ZENEO® injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female healthy volunteers aged between 18 and 60 years, affiliated to or covered by the French social security system, BMI between ≥20 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, Patients 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 (only for MRI sub study volunteers), Absence of cannabis, opiate, cocaine, amphetamine history (only for MRI sub study volunteers) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BMI < 25kg/m²<br>Subcutaneous high ZENEO® injection Intramuscular ZENEO® injection | Combination Product: Intramuscular ZENEO® injection<br>* Sodium Chloride (0.9 %)<br>Combination Product: Subcutaneous high ZENEO® injection<br>* Sodium Chloride (0.9 %)<br>|
| Other: 27.5 > BMI > 25 kg/m²<br>Intramuscular ZENEO® injection | Combination Product: Intramuscular ZENEO® injection<br>* Sodium Chloride (0.9 %)<br>|
| Other: BMI > 27.5 kg/m²<br>Intramuscular ZENEO® injection | Combination Product: Intramuscular ZENEO® injection<br>* Sodium Chloride (0.9 %)<br>|
| Other: No special BMI<br>Subcutaneous low ZENEO® injection | Combination Product: Subcutaneous low ZENEO® injection<br>* Sodium Chloride (0.9 %)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depth of the injection by MRI |  | 5 minutes after the injection |