Intradermal InjectionsEarly Phase 1MicronJetNCT00602914
A Pilot Study to Assess the Safety, PK and PD of Insulin Injected Via MicronJet or Conventional Needle
A Early Phase 1 study testing MicronJet in people with Intradermal Injections, run by NanoPass Technologies Ltd.
Trial summary
The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intradermal Injections
- What is being tested?
- MicronJet
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jul 2009
- Phase
- Early Phase 1
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Type 2 male patients and post-menopausal females aged 30-70 years.
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- HA1c 6.5-10%
- Naïve or treated with Metformin only
- BMI< 35
- 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.
Who cannot join
- 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.
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- 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
- Type 2 diabetic patients
- 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
About this study
Official title: 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
The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle.
Read the detailed description
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.
- Conditions
- Intradermal Injections
- Being tested
- MicronJet
- Keywords
- MicronJet (microneedles), Intradermal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicronJetDevice
The micronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the skin). In this study the MicronJet will be used to inject insulin vs. a convention needle injection.
MicronJetDevice
Also called Microneedles
MicronJet, Intradermal Injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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 Receives: Device: MicronJet |
| 2 | Experimental | 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 Receives: Device: MicronJet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood samples for PK and PD will be collected
Measured: pre dose and up to 360 minutes post dose of administration
Secondary outcomes (1)
Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires
Measured: All study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradermal InjectionsStudies 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
- Early Phase 1
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoPass Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Itamar Raz, MD, Principal investigator, Head, Diabetes Unit, Hadassah Medical Organization, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602914
- Sponsor's protocol ID
- NP-1-001
- Acronym
- MicronJet
- Status last verified
- Apr 2008
- First submitted
- 30 Dec 2007
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00602914
- Acronym / sponsor ID
- MicronJet / NP-1-001
- Conditions
- Intradermal Injections
- Keywords
- MicronJet (microneedles), Intradermal
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NanoPass Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 28 Jan 2008 (estimated)
- 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 purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle.
Detailed description
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: MicronJet10 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 |
| 2 | Experimental | Device: MicronJet10 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
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 |
|---|---|---|
| MicronJetThe micronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the skin). In this study the MicronJet will be used to inject insulin vs. a convention needle injection. | Device | 1, 2 |
| MicronJetAlso: MicroneedlesMicronJet, Intradermal Injection | Device | 1, 2 |
Primary outcome
Blood samples for PK and PD will be collected
Time frame: pre dose and up to 360 minutes post dose of administration
1 secondary outcome
Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires
Time frame: All study duration
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 10 May 2013.
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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.
Itamar Raz, MD principal investigator
Head, Diabetes Unit, Hadassah Medical Organization, Jerusalem, Israel
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MicronJet in people with Intradermal Injections, run by NanoPass Technologies Ltd.
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 11 inclusion and 25 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 10 May 2013. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood samples for PK and PD will be collected (time frame: pre dose and up to 360 minutes post dose of administration). 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 10 May 2013.