No ConditionNCT03225638
Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®)
A study testing Intramuscular ZENEO® injection of nominal strength, Intramuscular ZENEO® injection of low strength (upper limit) and Intramuscular ZENEO® injection of low strength (lower limit) in people with No Condition, run by Crossject.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- No Condition
- What is being tested?
- Intramuscular ZENEO® injection of nominal strength, Intramuscular ZENEO® injection of low strength (upper limit) and Intramuscular ZENEO® injection of low strength (lower limit)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 29 Dec 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- No Condition
- Being tested
- Intramuscular ZENEO® injection of nominal strength, Intramuscular ZENEO® injection of low strength (upper limit), Intramuscular ZENEO® injection of low strength (lower limit)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular ZENEO® injection of nominal strengthCombination product
Sodium Chloride (0.9%)
Intramuscular ZENEO® injection of low strength (upper limit)Combination product
Sodium Chloride (0.9%)
Intramuscular ZENEO® injection of low strength (lower limit)Combination product
Sodium Chloride (0.9%)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Nominal strength thigh injection of 0.65ml of saline solution (0.9%) Low threshold (upper limit) strength thigh injection of 0.65ml of saline solution (0.9%) Receives: Combination Product: Intramuscular ZENEO® injection of nominal strength; Combination Product: Intramuscular ZENEO® injection of low strength (upper limit) |
| Group 2 | Other | Nominal strength thigh injection of 0.65ml of saline solution (0.9%) Low threshold (lower limit) strength thigh injection of 0.65ml of saline solution (0.9%) Receives: Combination Product: Intramuscular ZENEO® injection of nominal strength; Combination Product: Intramuscular ZENEO® injection of low strength (lower limit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of the injection
Depth of the injection (mm) by MRI
Measured: 5 minutes after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Sep 2017 (estimated)
- Primary completion30 Sep 2017 (estimated)
- Study completion29 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No ConditionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crossject
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225638
- Sponsor's protocol ID
- CJT-CS-2017-01
- Status last verified
- Jul 2017
- First submitted
- 20 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®)
- ClinicalTrials.gov ID
- NCT03225638
- Acronym / sponsor ID
- CJT-CS-2017-01
- Conditions
- No Condition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- CrossjectIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 29 Dec 2017 (estimated)
- First posted
- 21 Jul 2017 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Combination Product: Intramuscular ZENEO® injection of nominal strength, Combination Product: Intramuscular ZENEO® injection of low strength (upper limit)Nominal strength thigh injection of 0.65ml of saline solution (0.9%) Low threshold (upper limit) strength thigh injection of 0.65ml of saline solution (0.9%) |
| Group 2 | Other | Combination Product: Intramuscular ZENEO® injection of nominal strength, Combination Product: Intramuscular ZENEO® injection of low strength (lower limit)Nominal strength thigh injection of 0.65ml of saline solution (0.9%) Low threshold (lower limit) strength thigh injection of 0.65ml of saline solution (0.9%) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Intramuscular ZENEO® injection of nominal strengthSodium Chloride (0.9%) | Combination product | Group 1, Group 2 |
| Intramuscular ZENEO® injection of low strength (upper limit)Sodium Chloride (0.9%) | Combination product | Group 1 |
| Intramuscular ZENEO® injection of low strength (lower limit)Sodium Chloride (0.9%) | Combination product | Group 2 |
Primary outcome
Depth of the injection
Time frame: 5 minutes after the injection
Depth of the injection (mm) by MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intramuscular ZENEO® injection of nominal strength, Intramuscular ZENEO® injection of low strength (upper limit) and Intramuscular ZENEO® injection of low strength (lower limit) in people with No Condition, run by Crossject.
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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CASTANO (0380549852, x.castano@crossject.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth of the injection (time frame: 5 minutes after the injection). 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 21 Jul 2017.