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

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.

Study Overview

• Status: Unknown
• Conditions: No Condition
• Intervention / Treatment: Combination product: Intramuscular ZENEO® injection of nominal strength; Combination product: Intramuscular ZENEO® injection of low strength (upper limit); Combination product: Intramuscular ZENEO® injection of low strength (lower limit)

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CASTANO; Phone Number: 0380549852; Email: x.castano@crossject.com

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 ≥ 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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%)	Combination product: Intramuscular ZENEO® injection of nominal strength; Sodium Chloride (0.9%); Combination product: Intramuscular ZENEO® injection of low strength (upper limit); Sodium Chloride (0.9%)
Other: 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%)	Combination product: Intramuscular ZENEO® injection of nominal strength; Sodium Chloride (0.9%); Combination product: Intramuscular ZENEO® injection of low strength (lower limit); Sodium Chloride (0.9%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depth of the injection	Depth of the injection (mm) by MRI	5 minutes after the injection

Collaborators and Investigators

• Sponsor: Crossject

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): September 30, 2017
• Study Completion (Anticipated): December 29, 2017

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 20, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CJT-CS-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No