Evaluation by Magnetic Resonance Imaging of Intramuscular Injections Performance in Thigh With 2 Configurations of the Needle-free Injector ZENEO®.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Crossject
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Intra-muscular injection success rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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).
结局指标
主要结局
Intra-muscular injection success rate
时间窗: 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
次要结局
- Occurence of local tolerability events(At 5 minutes after each injection with the ZENEO® injector at Day 1 of each treatment period)
- 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.)
- Injection parameters evaluated by MRI(Within 20 minutes after injection with the ZENEO® injector)
- Anthropometric characteristics of thighs (left and right) acquired by Ultrasound (no contrast agent will be used)(To be performed once during the study)