No Condition
Conditions
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.
Interventions
COMBINATION_PRODUCTIntramuscular ZENEO® injection of nominal strength
Sodium Chloride (0.9%)
COMBINATION_PRODUCTIntramuscular ZENEO® injection of low strength (upper limit)
Sodium Chloride (0.9%)
COMBINATION_PRODUCTIntramuscular ZENEO® injection of low strength (lower limit)
Sodium Chloride (0.9%)
Sponsors
Crossject
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depth of the injection | 5 minutes after the injection | Depth of the injection (mm) by MRI |
Contacts
Primary ContactCASTANO
Outcome results
None listed