Needle-free InjectorMRINCT05967013
Evaluation by Magnetic Resonance Imaging of Intramuscular Injections Performance in Thigh With 2 Configurations of the Needle-free Injector ZENEO®.
A study testing Injections in thigh of 0.625 mL of physiological serum with ZENEO® injector, on bare skin and through clothing. in people with Needle-free Injector, run by Crossject at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Needle-free Injector
- What is being tested?
- Injections in thigh of 0.625 mL of physiological serum with ZENEO® injector, on bare skin and through clothing.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2023to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- Known Contra-Indication to i.m. injection.
- Treatment with platelet inhibiting drugs within one week before inclusion.
- Treatment with anticoagulant within four weeks before inclusion.
- 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.
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- 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.
- Participation in another interventional clinical trial within 3 months prior to screening.
- In custody due to administrative or legal decision or under tutelage or being admitted in a sanitary or social institution.
- Vulnerable subjects, e.g. persons in detention.
- Subject is the Principal Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study or employee of the Sponsor (or representatives).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Injections in thigh of 0.625 mL of physiological serum with ZENEO® injector, on bare skin and through clothing.
- Keywords
- Needle-free injector, Magnetic Resonance Imaging, Intramuscular, Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Injections in thigh of 0.625 mL of physiological serum with ZENEO® injector, on bare skin and through clothing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 20 minutes after injection with the ZENEO® injector.
Secondary outcomes (4)
Injection parameters evaluated by MRI
- Distance in millimeters (mm) :
- Maximal vertical depth of the injection
- Length of the injectate run
- Width of the injectate in the muscle
- Maximum vertical depth of the injectate in the muscle
- Derma depth
- Skin-to-muscle distance
- Skin-to-bone distance
- Subcutaneous tissue thickness
- Fat thickness (when applicable)
- Volume in milliliters (mL) : . Estimated volume of physiological serum injected into the muscles
- Direction of injectate (head/Vertical/Foot)
- Imaging gradation :
- Image Quality (0 to 4)
- Visibility of injectate (0 to 4)
Measured: Within 20 minutes after injection with the ZENEO® injector
Occurence of local tolerability events
Any signs of erythema, swelling, bruising, allergic reaction and bleeding
Measured: 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)
- Derma depth (mm)
- Subcutaneous tissue depth (mm)
- Skin-to-muscle distance (mm)
- Skin-to-bone distance (mm)
- Fat thickness (when applicable(mm)
Measured: To be performed once during the study
Average pain rating
By using Visual Analogic Scale (VAS)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start12 Jun 2023
- Primary completion26 Oct 2023
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needle-free InjectorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crossject
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maxime LUU, MD, PhD, Principal investigator, CHU DIJON Bourgogne - Hôpital François Mitterrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967013
- Sponsor's protocol ID
- CJTMRIZ2101
- Acronym
- MRI
- Status last verified
- Mar 2024
- First submitted
- 20 Jul 2023
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation by Magnetic Resonance Imaging of Intramuscular Injections Performance in Thigh With 2 Configurations of the Needle-free Injector ZENEO®.
- ClinicalTrials.gov ID
- NCT05967013
- Acronym / sponsor ID
- MRI / CJTMRIZ2101
- Conditions
- Needle-free Injector
- Keywords
- Needle-free injector, Magnetic Resonance Imaging, Intramuscular, Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- CrossjectIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 4-period cross-over | Experimental | Combination Product: Injections in thigh of 0.625 mL of physiological serum with ZENEO® injector, on bare skin and through clothing.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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
- Female subjects of non-childbearing potential must be:
- 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.
Key exclusion criteria (21 listed)
- Known Contra-Indication to i.m. injection.
- Treatment with platelet inhibiting drugs within one week before inclusion.
- Treatment with anticoagulant within four weeks before inclusion.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | 4-period cross-over |
Primary outcome
Intra-muscular injection success rate
Time frame: Within 20 minutes after injection with the ZENEO® injector.
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
4 secondary outcomes
Injection parameters evaluated by MRI
Time frame: Within 20 minutes after injection with the ZENEO® injector
Occurence of local tolerability events
Time frame: 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)
Time frame: To be performed once during the study
Average pain rating
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime LUU, MD, PhD principal investigator
CHU DIJON Bourgogne - Hôpital François Mitterrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injections in thigh of 0.625 mL of physiological serum with ZENEO® injector, on bare skin and through clothing. in people with Needle-free Injector, run by Crossject at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-muscular injection success rate (time frame: Within 20 minutes after injection with the ZENEO® injector.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.