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

NCT03225638 | Unknown

• 1 other identifier: CJT-CS-2017-01
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

No Condition

Outcome Measures

Primary Outcomes (1)

• Depth of the injection

  Depth of the injection (mm) by MRI

  5 minutes after the injection

Study Arms (2)

Group 1

OTHER

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; Combination Product: Intramuscular ZENEO® injection of low strength (upper limit)

Group 2

OTHER

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; Combination Product: Intramuscular ZENEO® injection of low strength (lower limit)

Interventions

Intramuscular ZENEO® injection of nominal strength COMBINATION_PRODUCT

Sodium Chloride (0.9%)

Group 1; Group 2

Intramuscular ZENEO® injection of low strength (upper limit) COMBINATION_PRODUCT

Sodium Chloride (0.9%)

Group 1

Intramuscular ZENEO® injection of low strength (lower limit) COMBINATION_PRODUCT

Sodium Chloride (0.9%)

Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Absence of cannabis, opiate, cocaine, amphetamine history
• Written Informed consent

You may not qualify if:

• History of drug abuse
• History of hypersensitivity (disease or drug)
• 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

Sponsors & Collaborators

• Crossject: lead

Central Study Contacts

CASTANO

CONTACT

0380549852; x.castano@crossject.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 21, 2017
• Study Start: September 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: December 29, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07