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®)

Crossject

Status: Completed

Conditions: No Condition

Treatments: Combination Product: Intramuscular ZENEO® injection; Combination Product: Subcutaneous low ZENEO® injection; Combination Product: Subcutaneous high ZENEO® injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03044301

G-E-CJT-XC-150127

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 4 patient groups

BMI < 25kg/m²

Other group

Description:

Subcutaneous high ZENEO® injection Intramuscular ZENEO® injection

Treatment:

Combination Product: Intramuscular ZENEO® injection

Combination Product: Subcutaneous high ZENEO® injection

27.5 > BMI > 25 kg/m²

Other group

Description:

Intramuscular ZENEO® injection

Treatment:

Combination Product: Intramuscular ZENEO® injection

BMI > 27.5 kg/m²

Other group

Description:

Intramuscular ZENEO® injection

Treatment:

Combination Product: Intramuscular ZENEO® injection

No special BMI

Other group

Description:

Subcutaneous low ZENEO® injection

Treatment:

Combination Product: Subcutaneous low ZENEO® injection