An Open Label Study in Healthy Volunteers and Diabetes Mellitus Type II Subjects to Determine the Safety, Pharmacokinetics and Pharmacodynamics Profile of Insulin Injected by the MicronJet Device
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Blood samples for PK and PD will be collected
研究概览
简要总结
The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle.
详细描述
Administration of insulin to the skin has many potential advantages including improved kinetics and reduced pain. Today, insulin is injected to the SQ space, using, in most cases, various devices incorporating standard metal needles and usually causing considerable pain and discomfort to the patients. NanoPass has developed a microneedle based needle substitute for intradermal injections. This device requires minimal expertise and is expected to cause minimal or no pain during injections.
The objective of this study is to compare the pharmacokinetics and pharmacodynamics of insulin Novorapid® (Novo Nordisk) injected via the MicronJet device intradermally, to a conventional needle injected to the SQ space.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A. Healthy volunteers
- •Inclusion Criteria:
- •Men ranging in age from 18-40 years.
- •In good general health as determined by medical history, physical examination, ECG and clinical laboratory tests obtained with 14 days prior to the start of the study.
- •BMI<30 or the volunteer is not considered obese by the Principal Investigator with a written statement at screening.
- •Willing and able to abide by the dietary requirements of the study.
- •Willing and able to give written informed consent in a manner approved by the Institutional Review Board or Ethics Committee.
排除标准
- •History of known or suspected clinically significant hypersensitivity to any drug.
- •History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •Clinically significant cardiovascular, hepatic, gastrointestinal, metabolic, neurological, pulmonary, endocrine, psychiatric, coagulation or neoplastic disorders.
- •Participation in radiologic studies involving parenteral administration of iodinated contrast materials within two weeks prior to screening.
- •Subjects with history of recent alcohol abuse (defined as consumption of more than 21- ml of alcohol per week; or the equivalent of fourteen 4-oz glasses of wine, fourteen 12 oz can/bottle of beer or wine cooler) or other substance abuse.
- •Any protocol-required laboratory test abnormality that is considered clinically significant.
- •Participation in another investigational drug study within 90 days before the first day of dosing.
- •History of non-compliance to medical regimens, or subjects who are considered potentially unreliable.
- •Blood or plasma donation within the past 90 days.
- •Mentally unstable or incompetent.
- •Positive hepatitis C screen or positive hepatitis B screen.
- •HIV positive
- •B. Type 2 diabetic patients
- •Inclusion Criteria:
- •Type 2 male patients and post-menopausal females aged 30-70 years.
- •HA1c 6.5-10%
- •Naïve or treated with Metformin only
- •Willing and able to abide by the dietary requirements of the study.
- •Willing and able to give written informed consent in a manner approved by the Institutional Review Board or Ethics Committee.
- •Exclusion Criteria:
- •History of known or suspected clinically significant hypersensitivity to any drug.
- •History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •Clinically significant cardiovascular, hepatic, gastrointestinal, metabolic, neurological, pulmonary, endocrine, psychiatric, coagulation or neoplastic disorders.
- •Participation in radiologic studies involving parenteral administration of iodinated contrast materials within two weeks prior to screening.
- •Subjects with history of recent alcohol abuse (defined as consumption of more than 21- ml of alcohol per week; or the equivalent of fourteen 4-oz glasses of wine, fourteen 12 oz can/bottle of beer or wine cooler) or other substance abuse.
- •Any protocol-required laboratory test abnormality that is considered clinically significant.
- •Participation in another investigational drug study within 90 days before the first day of dosing.
- •History of non-compliance to medical regimens, or subjects who are considered potentially unreliable.
- •Blood or plasma donation within the past 90 days.
- •Mentally unstable or incompetent.
- •Positive hepatitis C screen or positive hepatitis B screen.
- •HIV positive
研究组 & 干预措施
1
10 healthy volunteers will receive 0.1 U/kg. Once administered with a conventional needle (SQ) and then with MicronJet needle (ID) in a randomized order
干预措施: MicronJet (Device)
2
10 Type II DM subject will receive 0.2 U/kg. Once administered with a conventional needle (SQ) and then with MicronJet needle (ID) in a randomized order
干预措施: MicronJet (Device)
结局指标
主要结局
Blood samples for PK and PD will be collected
时间窗: pre dose and up to 360 minutes post dose of administration
次要结局
- Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires(All study duration)