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®)

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.

Study Overview

• Status: Completed
• Conditions: No Condition
• Intervention / Treatment: Combination product: Intramuscular ZENEO® injection; Combination product: Subcutaneous high ZENEO® injection; Combination product: Subcutaneous low ZENEO® injection

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Crossject

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: G-E-CJT-XC-150127