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

NCT05967013 | Completed

• 1 other identifier: CJTMRIZ2101
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Needle-free Injector

Keywords

Needle-free injector; Magnetic Resonance Imaging; Intramuscular; Injection

Outcome Measures

Primary Outcomes (1)

• Intra-muscular injection success rate

  The intra-muscular injection success rate defined as the muscle fascias are crossed by the saline solution as objectified by MRI: * Success of crossing the muscle fascia defined as injection 'depth in the muscle greater than 0 mm * Success of intra-muscular injection defined as injection 'depth in the muscle greater than 5 mm

  Within 20 minutes after injection with the ZENEO® injector.

Secondary Outcomes (4)

• Injection parameters evaluated by MRI

  Within 20 minutes after injection with the ZENEO® injector

• Occurence of local tolerability events

  At 5 minutes after each injection with the ZENEO® injector at Day 1 of each treatment period

• Anthropometric characteristics of thighs (left and right) acquired by Ultrasound (no contrast agent will be used)

  To be performed once during the study

• Average pain rating

  At 5 minutes after each injection with the ZENEO® injector at Day 1, after each MRI and at each follow-up visit (Day 3 and Day 6) of each treatment period.

Other Outcomes (1)

• Safety Outcomes and Evaluation

  At Day +8 after the last injection with the ZENEO® injector.

Study Arms (1)

4-period cross-over

EXPERIMENTAL

After a screening period of a maximum of 21 days, eligible subjects will be randomized in a 1:1:1:1 allocation ratio to one of the 4 treatment sequences (settings): * Sequence 1: A\&B in Period 1 / C\&D in Period 2 * Sequence 2: D\&A in Period 1 / B\&C in Period 2 * Sequence 3: C\&D in Period 1 / A\&B in Period 2 * Sequence 4: B\&C in Period 1 / D\&A in Period 2 Setting definitions: * Setting B = volume "0.64mL" of physiological serum with ZENEO® injector, setting "GAMMA" - Bare skin. * Setting A = volume "0.64mL" of physiological serum with ZENEO® injector, setting "GAMMA" - Through Clothing. * Setting D = volume "0.64mL" of physiological serum with ZENEO® injector, setting "GAMMA low" - Bare skin. * Setting C = volume "0.64mL" of physiological serum with ZENEO® injector, setting "GAMMA low" - Through Clothing.

Combination Product: Injections in thigh of 0.625 mL of physiological serum with ZENEO® injector, on bare skin and through clothing.

Interventions

Injections in thigh of 0.625 mL of physiological serum with ZENEO® injector, on bare skin and through clothing. COMBINATION_PRODUCT

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.

4-period cross-over

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female volunteers aged between 18 and 59 years (inclusive) at the Screening Visit.
• Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile: neither post-menopausal nor surgically sterile) who are sexually active with a non-sterile male partner must be willing to use one of the following effective contraceptive methods throughout the study and for 30 days after the last study intervention:
• Combined estrogen and progestogen-containing or progestogen-only hormonal contraception associated with inhibition of ovulation, started at least 4 weeks prior to the first study intervention;
• Intrauterine device placed at least 4 weeks prior to the first study intervention, and condom for the male partner;
• Simultaneous use of a diaphragm or cervical cap with intravaginally applied spermicide and for the male partner a male condom;
• Sterile male partner (i.e. vasectomized since at least 6 months prior to the first study intervention);
• Sexual abstinence (when in line with the preferred and usual subject lifestyle). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
• Female subjects of non-childbearing potential must be:
• Post-menopausal female (absence of menses for 12 months prior to the first \[if applicable\] study intervention); or
• Surgically sterile female (documented hysterectomy, or bilateral oophorectomy or bilateral tubal ligation/occlusion) or bilateral tubal ligation at least 6 months prior to the first \[if applicable\] study intervention).
• Subject with BMI between ≥ 16.0 and \< 35.0 kg/m² at the Screening Visit.
• Injection sites must be clear of tattoos, scars and moles.
• Affiliated to or covered by the French social security system.
• Signed written consent given for participation in the study.

You may not qualify if:

• Known Contra-Indication to i.m. injection.
• Any Contra-indication to MRI (ex: metallic intra-corporeal devices, claustrophobia, tremor or abnormal movements whatever the origin is).
• A major illness during the 3 months before the screening period, that may interfere with the evaluation, as judged by the investigator
• Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the Investigator.
• Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or admission to the clinical unit.
• A pulse \< 45 or \> 90 bpm; mean systolic blood pressure \> 140 mmHg; mean diastolic blood pressure \> 90 mmHg (measurements taken in triplicate after subject has been resting in supine position for 5 minutes.
• Current alcohol use \> 21 units of alcohol per week for males and \> 14 units of alcohol per week for females.
• Regular exposure to substances of abuse (other than alcohol) within the past year.
• Positive urine screen for drugs of abuse and for alcohol breath test at screening and before the first study intervention (P1). In case of a positive result, urine screen for drugs may be repeated once at the discretion of the Investigator.
• Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first use of the Investigational Medicinal Device.
• History of hypersensitivity or allergy to any topical disinfectant.
• Positive testing at screening for current infection Human Immunodeficiency Virus (HIV), Hepatitis B and/or Hepatitis C.
• Breastfeeding woman.
• Positive pregnancy test at screening (β-Human Chorionic Gonadotropin test) and Check-in (Day1-P1) (urine test).
• Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Sponsors & Collaborators

• Crossject: lead

Study Sites (1)

CHU DIJON Bourgogne - Hôpital François Mitterrand

Dijon, 21079, France

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Maxime LUU, MD, PhD

  CHU DIJON Bourgogne - Hôpital François Mitterrand

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: An open-label single-dose, 4-period cross-over, randomized, non-comparative mono-centric study where 0.625 mL of a saline solution will be injected in the thigh (on bare skin or through clothing) with the ZENEO® injector to healthy subjects.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: June 12, 2023
• Primary Completion: October 26, 2023
• Study Completion: February 16, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)