NCT05967013

Evaluation by Magnetic Resonance Imaging of Intramuscular Injections Performance in Thigh With 2 Configurations of the Needle-free Injector ZENEO®.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Crossject · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to establish with measures of clinical parameters by Magnetic Resonance Imaging (MRI) (e.g. crossing of the muscle fascias, length of run, injection depth, volume injected) performance of 2 configurations of the needle-free injector when used for intramuscular injection on bare skin or through clothing.

Detailed description

The development of needle-free injection devices has been motivated by a need for safer and more user-friendly injection devices that can prevent needle-stick injuries and contamination as well as improve patient comfort and treatment. As a growing number of drugs need to be injected or self-injected, needle-free devices are an attractive alternative to the conventional needle, especially in situation of emergency. A medical emergency requires quick action to ward off a risk of imminent death and long-term sequelae, or to manage a situation of stress or crisis. Study's sponsor has developed an innovative, needle-free, prefilled, single use, disposable injector called ZENEO®. Unlike other needle-free injection devices, ZENEO® does not resemble a syringe in order to make injections with the device as natural and user friendly The prefilled, single use, combined system of ZENEO® makes it ready to use for any type of drug or vaccine that needs to be injected into the skin (intradermal), under the skin (subcutaneous) or into the muscle (intramuscular). According to regulatory requirements for market-authorization submission, proof of performance of ZENEO® injector for intramuscular (i.m.) injection must be established. For each drug development as combination with the ZENEO® injector, clinical investigations will be conducted to study the relative bioavailability of the medicinal product when injected either with ZENEO® or with a conventional syringe. Performance profile of ZENEO® injector for i.m. injection on the thigh with a target volume of 0.625 milliliter (mL) of an aqueous solution have been calculated and must be verified by clinical data in order to demonstrate successful delivery of the intended medication(s) to the target tissues, achieving therapeutic bioavailability, or reaching another appropriate endpoint in humans. This is the reason why this clinical study CJTMRIZ2101 will be conducted. After a screening period of a maximum of 21 days, eligible subjects will be randomized in a 1:1:1:1 allocation ratio and will receive 2 intramuscular injections on the thigh with ZENEO® pre-filled with 0.64 mL of physiological serum, at 2 treatments periods - Period 1 (P1) and Period 2 (P2) - separated by a wash-out period of at least 7 days. Each injection will be spaced of no more than 5 minutes. Within 10 minutes after the first injection and no more than 5 minutes after the second injection, subjects will be settled for the MRI sequences acquisition (about 20 minutes) so that the MRI acquisition should end no more than 30 minutes (+/- 5 minutes) after the first injection. A follow-up visit (phone contact) will systematically be performed two days after Day 1 of P1 and Day 1 of P2, in order to confirm there is no safety concern on the injection site and to confirm the subject's well-being. If a subject indicates a pain score \>5 or any significant anomaly an on-site follow-up visit will be organized within 7 days after each follow-up phone call. A total of 50 healthy volunteers will be enrolled in this investigation with at least 30% of males and 30% of females are expected.

Conditions

• Needle-free Injector

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Injections in thigh of 0.625 mL of physiological serum with ZENEO® injector, on bare skin and through clothing.	All injections with ZENEO® injector will be performed in the thigh. Due to MRI performance constraints, injection sites will be identified on the same thigh/leg at each treatment period: first leg on treatment period 1, opposite leg on treatment period 2. At each treatment period, two injection sites will be identified spaced 8 to 15 cm apart. The 2 injections should be performed on the same leg at each treatment period. In total, 2 injections will be performed per treatment period, and subjects will receive 4 injections during the study : * 2 injections on bare skin: 1 with GAMMA configuration of ZENEO® injector \& 1 with GAMMA-Low configuration ZENEO® injector. * 2 injections through clothing: 1 with GAMMA configuration of ZENEO® injector \& 1 with GAMMA-Low configuration ZENEO® injector.

Timeline

• Start date: 2023-06-12
• Primary completion: 2023-10-26
• Completion: 2024-02-16
• First posted: 2023-08-01
• Last updated: 2024-04-01

Locations

1 site across 1 country: France