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

No Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03225638
• Other study ID #: CJT-CS-2017-01
• Status: Not yet recruiting
• Phase: N/A
• First received: July 20, 2017
• Last updated: July 20, 2017
• Start date: September 1, 2017
• Est. completion date: December 29, 2017

Study information

• Verified date: July 2017
• Source: Crossject
• Contact: CASTANO
• Phone: 0380549852
• Email: x.castano[@]crossject.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: December 29, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• No Condition

Intervention

Combination Product:
• Intramuscular ZENEO® injection of nominal strength
Sodium Chloride (0.9%)
• Intramuscular ZENEO® injection of low strength (upper limit)
Sodium Chloride (0.9%)
• Intramuscular ZENEO® injection of low strength (lower limit)
Sodium Chloride (0.9%)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Crossject

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depth of the injection	Depth of the injection (mm) by MRI	5 minutes after the injection