Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®)

Not Applicable

• Conditions: No Condition
• Interventions: Combination Product: Intramuscular ZENEO® injection of nominal strength; Combination Product: Intramuscular ZENEO® injection of low strength (lower limit); Combination Product: Intramuscular ZENEO® injection of low strength (upper limit)

• Registration Number: NCT03225638
• Lead Sponsor: Crossject

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-20
• Last Update Submitted: 2017-07-20
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21
• Study Start: 2017-09-01
• Primary Completion: 2017-09-30
• Study Completion: 2017-12-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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 ≥ 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

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
• pregnant or breastfeeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Intramuscular ZENEO® injection of nominal strength	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%)
Group 2	Intramuscular ZENEO® injection of nominal strength	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%)
Group 2	Intramuscular ZENEO® injection of low strength (lower limit)	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%)
Group 1	Intramuscular ZENEO® injection of low strength (upper limit)	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%)

Primary Outcome Measures

Name	Time	Method
Depth of the injection	5 minutes after the injection	Depth of the injection (mm) by MRI